TremorNCT02087046
Deep Brain Stimulation (DBS) for the Suppression of Tremor
A study testing ANS Totally Implantable Deep Brain Stimulation System in people with Tremor and Action Tremor, run by Abbott Medical Devices at 12 sites in United States.
Trial summary
The purpose of the proposed study is to demonstrate the safety and efficacy of the ANS Totally Implantable Deep Brain Stimulation System in the VIM nucleus of the thalamus implanted for the treatment of tremor due to essential tremor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tremor, Action Tremor, Essential Tremor
- What is being tested?
- ANS Totally Implantable Deep Brain Stimulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 12 sitesUnited States
- Study dates
- Oct 2005to Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient or authorized representative has signed an informed consent.
- Patient is over 18 years of age.
- Patient is diagnosed with essential tremor for at least 3 years.
- Patient has a disabling medical-refractory upper extremity tremor with no evidence of supraspinal central nervous system disease or injury (tremor not adequately controlled by medications for at least three (3) months before implant).
- Patient has a postural or kinetic tremor severity score of at least 3 out of 4 in the extremity intended for treatment on the Fahn-Tolosa-Marin Clinical Rating Scale for Tremor.
- Patient will maintain a constant dose of anti-tremor medication indicated as best medical management for one (1) month prior to enrollment in study.
- Patient is available for appropriate follow-up times for the length of the study.
Who cannot join
- Patient is not surgical candidate;
- Patient has other clinically or medically significant disease;
- Patient has any neurological injury or disease other than essential tremor;
- Patient has any condition requiring repeated MRI scans;
- Patient has any condition requiring diathermy;
- Patients on anticoagulant medications;
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- Patient has untreated clinically significant depression;
- Patient has had an electrical or electromagnetic implant (cochlear prosthesis, pacemaker etc);
- Patient has had a prior thalamotomy or surgical ablation procedure in either side of the brain;
- Patient has dementia interfering with their ability to co-operate or comply with study requirements or comprehend the informed consent (mini-mental exam score <24);
- Patient abuses drugs or alcohol;
- Patient has had botulinum toxin injections in the six (6) months prior to enrollment;
- Patient has a history of cranial surgery;
- Patient has a history of seizures;
- Patient has any metallic implants that may interfere with the functioning of the device (e.g. aneurysm clips);
- Patient has a history of stimulation intolerance in any area of the body;
- Patient is a female of child bearing potential with a positive urine pregnancy test or not using adequate contraception.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Neurology Specialists of Dallas
Dallas, Texas, 75231
Oakwood Hospital
Dearborn, Michigan, 48124
University of Florida
Gainesville, Florida, 32610
Baylor College of Medicine
Houston, Texas, 77030
Mayo Clinic
Jacksonville, Florida, 32224
Loma Linda University School of Medicine
Loma Linda, California, 92354
Vanderbilt University
Nashville, Tennessee, 37212
Columbia University Medical Center
New York, New York, 10032
Pacific Hills Neurosurgery Medical Group
Pasadena, California, 91105
University of Rochester
Rochester, New York, 14618
University of San Francisco
San Francisco, California, 94122
About this study
Official title: A Clinical Evaluation of the Advanced Neuromodulation System (ANS) Totally Implantable Deep Brain Stimulation System for the Suppression of Tremor in the Upper Extremities of Patients With Essential Tremor.
The purpose of the proposed study is to demonstrate the safety and efficacy of the ANS Totally Implantable Deep Brain Stimulation System in the VIM nucleus of the thalamus implanted for the treatment of tremor due to essential tremor.
This study will be included in the Pre-Market Approval Application to support the safety of this device in use.
Read the detailed description
This study is designed as a prospective, multi-centered study for 365 days in duration from device implantation. A maximum of 12 sites will enroll 160 patients.
Each patient will be screened and then undergo a baseline evaluation followed by unilateral or bilateral implantation of the DBS system. During the implantation procedure, each patient will undergo a trial of stimulation in the operating room. The device may be internalized after a successful intra-operative trial or at a later surgery (no later than 4 weeks after initial lead placement). If the device is not activated immediately postsurgery, the patient may return to the clinic to determine optimum stimulation programming. Device programming will be optimized in as many visits as necessary following implantation. The day that the device is fully implanted will be classified as "Day 0" for each patient.
After "Day 0" the patient will return to clinic for evaluations at, Day 90 (±14 days), and Day 180 (±14 days) and Day 365 (approximately 12 months ± 30 days after Day 0). These evaluations consist of the CRST, the QUEST, the SF36, Patient and caregiver Global Ratings and the Patient Satisfaction Rating.
At Baseline and Day 180, the CRST evaluation session will be video recorded for analysis by an independent evaluator unaware of the functioning of the device. Additionally, at the Day 180 visit, the physician will have the option to provide the patient with amplitude control. A comparison of measures within the same person from pre-treatment to post-treatment will be performed. Also, pre-treatment and post-treatment group means and standard deviations will be determined.
Patients completed follow-up visits as part of the original protocol (C-04-02) for one year (or in some cases longer if patient was bilaterally implanted) and continued to complete additional visits as part of the Long-Term Follow-up protocol (C-06-03) for up to 5 years post implant.
- Conditions
- Tremor, Action Tremor, Essential Tremor, Tremor, Limb
- Being tested
- ANS Totally Implantable Deep Brain Stimulation System
- Medical subject headings
- Tremor, Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANS Totally Implantable Deep Brain Stimulation SystemDevice
ANS Totally Implantable Deep Brain Stimulation System will be implanted in the VIM nucleus of the thalamus
| Study group | Role | What they receive |
|---|---|---|
| Stimulation | Other | ANS Totally Implantable Deep Brain Stimulation System Receives: Device: ANS Totally Implantable Deep Brain Stimulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint: Difference in the Postural Tremor Score of the Target Limb Between Stimulation On and Stimulation Off, As Assessed by the Blind Reviewer
The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.
Measured: Day 180
Primary Safety Endpoint: Percentage of Participants With Device-related or Procedure Related Adverse Events
Percentage of device-related or procedure related adverse events will be assessed within 6 months following the initial unilateral implant. All such adverse events will be counted for 180 days following surgery or until the day of the second implant, which ever comes first.
Measured: Within 180 days following the initial implant
Secondary outcomes (65)
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Target Limb Severity Score, As Assessed by the Site Physician
The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.
Measured: Baseline
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Target Limb Severity Score, As Assessed by the Site Physician
The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.
Measured: Day 90
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Target Limb Severity Score, As Assessed by the Site Physician
The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.
Measured: Day 180
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Target Limb Severity Score, As Assessed by the Site Physician
The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.
Measured: Day 365
Clinical Rating Scale for Tremor (CRST) Evaluation- Target Limb Responder Analysis, As Assessed by the Site Physician
The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.
During responder analysis, a 2-point reduction in kinetic tremor or postural tremor between stimulation Off and stimulation On show an improvement in activities of daily living was considered a response, was also performed using the site physician's ratings.
Measured: Day 90
Clinical Rating Scale for Tremor (CRST) Evaluation- Target Limb Responder Analysis, As Assessed by the Site Physician
The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.
During responder analysis, a 2-point reduction in kinetic tremor or postural tremor between stimulation Off and stimulation On show an improvement in activities of daily living was considered a response, was also performed using the site physician's ratings.
Measured: Day 180
Clinical Rating Scale for Tremor (CRST) Evaluation- Target Limb Responder Analysis, As Assessed by the Site Physician
The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.
During responder analysis, a 2-point reduction in kinetic tremor or postural tremor between stimulation Off and stimulation On show an improvement in activities of daily living was considered a response, was also performed using the site physician's ratings.
Measured: Day 365
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Handwriting for Target Side Severity Score, As Assessed by the Site Physician
The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.
The site physician will evaluate the patient's handwriting according to the CRST (scale 0-4).
Measured: Baseline
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Handwriting for Target Side Severity Score, As Assessed by the Site Physician
The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.
The site physician will evaluate the patient's handwriting according to the CRST (scale 0-4).
Measured: Day 90
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Handwriting for Target Side Severity Score, As Assessed by the Site Physician
The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.
The site physician will evaluate the patient's handwriting according to the CRST (scale 0-4).
Measured: Day 180
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Handwriting for Target Side Severity Score, As Assessed by the Site Physician
The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.
The site physician will evaluate the patient's handwriting according to the CRST (scale 0-4).
Measured: Day 365
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Handwriting for Target Side Severity Score, As Assessed by the Blind Reviewer
The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.
The blind reviewer will evaluate the patient's handwriting according to the CRST (scale 0-4).
Measured: Day 180
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Pouring From Target Side Severity Scores, As Assessed by the Site Physician
The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.
The site physician will evaluate the patient's pouring ability according to the CRST
Measured: Baseline
Clinical Rating Scale for Tremor (CRST) Evaluation-Mean Pouring From Target Side Severity Scores, As Assessed by the Site Physician
The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.
The site physician will evaluate the patient's pouring ability according to the CRST
Measured: Day 90
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Pouring From Target Side Severity Scores, As Assessed by the Site Physician
The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.
The site physician will evaluate the patient's pouring ability according to the CRST
Measured: Day 180
Clinical Rating Scale for Tremor (CRST) Evaluation-Mean Pouring From Target Side Severity Scores, As Assessed by the Site Physician
The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.
The site physician will evaluate the patient's pouring ability according to the CRST
Measured: Day 365
Clinical Rating Scale for Tremor (CRST) Evaluation- Pouring Ability From Target Side Severity Scores, As Assessed by the Blind Reviewer
The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.
The blind reviewer will evaluate the patient's pouring ability according to the CRST
Measured: Day 180
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Total Motor Score, As Assessed by the Site Physician
The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.
The motor score adds together all responses to the tremor assessment for questions 1-9 of the CRST (whether or not the specific side is being treated).
Measured: Baseline
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Total Motor Score, As Assessed by the Site Physician
The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.
The motor score adds together all responses to the tremor assessment for questions 1-9 of the CRST (whether or not the specific side is being treated).
Measured: Day 90
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Total Motor Score, As Assessed by the Site Physician
The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.
The motor score adds together all responses to the tremor assessment for questions 1-9 of the CRST (whether or not the specific side is being treated).
Measured: Day 180
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Total Motor Score, As Assessed by the Site Physician
The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.
The motor score adds together all responses to the tremor assessment for questions 1-9 of the CRST (whether or not the specific side is being treated).
Measured: Day 365
Clinical Rating Scale for Tremor (CRST) Evaluation- Activity of Daily Living Score, As Assessed by the Site Physician
The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.
The activity of daily living score adds together all responses to questions 15-21 of the CRST.
Measured: Baseline
Clinical Rating Scale for Tremor (CRST) Evaluation- Activity of Daily Living Score, As Assessed by the Site Physician
The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.
The activity of daily living score adds together all responses to questions 15-21 of the CRST.
Measured: Day 90
Clinical Rating Scale for Tremor (CRST) Evaluation- Activity of Daily Living Score, As Assessed by the Site Physician
The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. The activity of daily living score adds together all responses to questions 15-21 of the CRST.
Measured: Day 180
Clinical Rating Scale for Tremor (CRST) Evaluation- Activity of Daily Living Score, As Assessed by the Site Physician
The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. The activity of daily living score adds together all responses to questions 15-21 of the CRST.
Measured: Day 365
Clinical Rating Scale for Tremor (CRST) Evaluation-Bilateral Stimulation, As Assessed by the Site Physician
The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.
For those patients that had bilateral stimulation, the site physician will evaluate the patient's non-target side after 180 days of bilateral stimulation.
Measured: Baseline
Clinical Rating Scale for Tremor (CRST) Evaluation-Bilateral Stimulation, As Assessed by the Site Physician
The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.
For those patients that had bilateral stimulation, the site physician will evaluate the patient's non-target side after 180 days of bilateral stimulation.
Measured: Following 180 days of stimulation
Clinical Rating Scale for Tremor (CRST) Evaluation-Non-Target Limb Severity Scores, As Assessed by the Site Physician
The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.
For those patients that had bilateral stimulation, the site physician will evaluate the patient's non-target side after 180 days with only the second side system On
Measured: Baseline
Clinical Rating Scale for Tremor (CRST) Evaluation-Non-Target Limb Severity Scores, As Assessed by the Site Physician
The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.
For those patients that had bilateral stimulation, the site physician will evaluate the patient's non-target side after 180 days with only the second side system On
Measured: Following 180 days of stimulation
Quality of Life in Essential Tremor (QUEST): Overall Summary Index
The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. As the scores were expressed as percentages, if a question was unanswered it was excluded and percentages were calculated based on the remaining answers. A total or quest summary index (QSI) was computed by calculating the mean of the five scales. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life.
Measured: Baseline
Change From Baseline for Quality of Life in Essential Tremor (QUEST): Overall Summary Index
The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. As the scores were expressed as percentages, if a question was unanswered it was excluded and percentages were calculated based on the remaining answers. A total or quest summary index (QSI) was computed by calculating the mean of the five scales. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life.
Measured: Day 90
Change From Baseline for Quality of Life in Essential Tremor (QUEST): Overall Summary Index
The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. As the scores were expressed as percentages, if a question was unanswered it was excluded and percentages were calculated based on the remaining answers. A total or quest summary index (QSI) was computed by calculating the mean of the five scales. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life.
Measured: Day 180
Change From Baseline for Quality of Life in Essential Tremor (QUEST): Overall Summary Index
The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. As the scores were expressed as percentages, if a question was unanswered it was excluded and percentages were calculated based on the remaining answers. A total or quest summary index (QSI) was computed by calculating the mean of the five scales. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life.
Measured: Day 365
SF36 Components and Individual Domains
The SF-36 questionnaire is a measure of health status with 36 items across 8 domains. The eight domains are separated into two summary scores of four domains, the physical component summary (PCS) and mental component summary (MCS). The SF-36 score is transformed into a scale of 0-100, with 100 indicating no disability. PCS and MCS are scaled in comparison to population norms to reflect a mean of 50 and standard deviation of 10 for the general population of the United States.
Measured: Baseline
SF36 Components and Individual Domains
The SF-36 questionnaire is a measure of health status with 36 items across 8 domains. The eight domains are separated into two summary scores of four domains, the physical component summary (PCS) and mental component summary (MCS). The SF-36 score is transformed into a scale of 0-100, with 100 indicating no disability. PCS and MCS are scaled in comparison to population norms to reflect a mean of 50 and standard deviation of 10 for the general population of the United States.
Measured: Day 90
SF36 Components and Individual Domains
The SF-36 questionnaire is a measure of health status with 36 items across 8 domains. The eight domains are separated into two summary scores of four domains, the physical component summary (PCS) and mental component summary (MCS). The SF-36 score is transformed into a scale of 0-100, with 100 indicating no disability. PCS and MCS are scaled in comparison to population norms to reflect a mean of 50 and standard deviation of 10 for the general population of the United States.
Measured: Day 180
SF36 Components and Individual Domains
The SF-36 questionnaire is a measure of health status with 36 items across 8 domains. The eight domains are separated into two summary scores of four domains, the physical component summary (PCS) and mental component summary (MCS). The SF-36 score is transformed into a scale of 0-100, with 100 indicating no disability. PCS and MCS are scaled in comparison to population norms to reflect a mean of 50 and standard deviation of 10 for the general population of the United States.
Measured: Day 365
Global Assessment Scores by Examiner
Global outcome measures are a self-rated questionnaire that measures a global assessment of the patient quality of life and the examiner's interpretation of the patient's quality of life.
Measured: Baseline
Global Assessment Scores by Examiner
Global outcome measures are a self-rated questionnaire that measures a global assessment of the patient quality of life and the examiner's interpretation of the patient's quality of life.
Measured: Day 90
Global Assessment Scores by Examiner
Global outcome measures are a self-rated questionnaire that measures a global assessment of the patient quality of life and the examiner's interpretation of the patient's quality of life.
Measured: Day 180
Global Assessment Scores by Examiner
Global outcome measures are a self-rated questionnaire that measures a global assessment of the patient quality of life and the examiner's interpretation of the patient's quality of life.
Measured: Day 365
Global Assessment by Caregiver
Global outcome measures are a self-rated questionnaire that measures a global assessment of the patient quality of life and the caregiver's interpretation of the patient's quality of life
Measured: Baseline
Global Assessment by Caregiver
Global outcome measures are a self-rated questionnaire that measures a global assessment of the patient quality of life and the caregiver's interpretation of the patient's quality of life
Measured: Day 90
Global Assessment by Caregiver
Global outcome measures are a self-rated questionnaire that measures a global assessment of the patient quality of life and the caregiver's interpretation of the patient's quality of life
Measured: Day 180
Global Assessment by Caregiver
Global outcome measures are a self-rated questionnaire that measures a global assessment of the patient quality of life and the caregiver's interpretation of the patient's quality of life
Measured: Day 365
Global Assessment by Patient
Global outcome measures are a self-rated questionnaire in which patients assess their own global outcome at each visit
Measured: Baseline
Global Assessment by Patient
Global outcome measures are a self-rated questionnaire in which patients assess their own global outcome at each visit
Measured: Day 90
Global Assessment by Patient
Global outcome measures are a self-rated questionnaire in which patients assess their own global outcome at each visit
Measured: Day 180
Global Assessment by Patient
Global outcome measures are a self-rated questionnaire in which patients assess their own global outcome at each visit
Measured: Day 365
Subjective Assessment by Patient Since Activation of System
Subjective assessment includes changes in their ET symptoms since the last visit indicated as marked improvement, moderate improvement, mild improvement, worsening, or no change.
Measured: Day 90
Subjective Assessment by Patient Since Activation of System
Subjective assessment includes changes in their ET symptoms since the last visit indicated as marked improvement, moderate improvement, mild improvement, worsening, or no change.
Measured: Day 180
Subjective Assessment by Patient Since Activation of System
Subjective assessment includes changes in their ET symptoms since the last visit indicated as marked improvement, moderate improvement, mild improvement, worsening, or no change.
Measured: Day 365
Number of Participants With Satisfaction With the DBS System's Functioning and Ability to Control Symptoms
At each visit, patients will be asked about their satisfaction with the DBS system's functioning and ability to control symptoms
Measured: Day 90
Number of Participants With Satisfaction With the DBS System's Functioning and Ability to Control Symptoms
At each visit, patients will be asked about their satisfaction with the DBS system's functioning and ability to control symptoms
Measured: Day 180
Number of Participants With Satisfaction With the DBS System's Functioning and Ability to Control Symptoms
At each visit, patients will be asked about their satisfaction with the DBS system's functioning and ability to control symptoms
Measured: Day 365
Number of Participants Who Would Choose to Receive the DBS System Again
At each visit, patients will be asked if they would undergo the DBS procedure again
Measured: Day 90
Number of Participants Who Would Choose to Receive the DBS System Again
At each visit, patients will be asked if they would undergo the DBS procedure again
Measured: Day 180
Number of Participants Who Would Choose to Receive the DBS System Again
At each visit, patients will be asked if they would undergo the DBS procedure again
Measured: Day 365
Number of Participants Who Would Recommend the DBS System
At each visit, patients will be asked if they would recommend the DBS system to others
Measured: Day 90
Number of Participants Who Would Recommend the DBS System
At each visit, patients will be asked if they would recommend the DBS system to others
Measured: Day 180
Number of Participants Who Would Recommend the DBS System
At each visit, patients will be asked if they would recommend the DBS system to others
Measured: Day 365
Beck Depression Inventory II (BDI - II) Score for Depression Symptoms
The Beck Depression Inventory II is A clinical rating scale designed for detecting depression based on the Diagnostic and Statistical Manual of Mental Health Disorders-Fourth Edition (DSM-IV) criteria. This widely used instrument consists of 21 items to assess the intensity of depression in clinical and normal patients. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. The BDI II questionnaire contains 21 questions, each answer being scored on a scale value of 0 to 3. A score between 0-13 indicates minimal depression, 14-19 mild depression, 20-28 moderate depression and 29-63 severe depression. Total scores are obtained by computing the sum of each score. The scores range from 0 to 63, with higher score indicating greater severity of depressive symptoms.
Measured: Baseline
Change From Baseline in Beck Depression Inventory II (BDI - II) Score for Depression Symptoms
The Beck Depression Inventory II is A clinical rating scale designed for detecting depression based on the Diagnostic and Statistical Manual of Mental Health Disorders-Fourth Edition (DSM-IV) criteria. This widely used instrument consists of 21 items to assess the intensity of depression in clinical and normal patients. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. The BDI II questionnaire contains 21 questions, each answer being scored on a scale value of 0 to 3. A score between 0-13 indicates minimal depression, 14-19 mild depression, 20-28 moderate depression and 29-63 severe depression. Total scores are obtained by computing the sum of each score. The scores range from 0 to 63, with higher score indicating greater severity of depressive symptoms.
Measured: Day 365
Mini Mental State Exam (MMSE) for Examination of Mental Status
The Mini-Mental State Examination (MMSE) is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It examines functions including registration (repeating named prompts), attention and calculation, recall, language, ability to follow simple commands and orientation. Any score of 24 or more (out of 30) indicates a normal cognition.
Measured: Baseline
Change From Baseline in Mini Mental State Exam (MMSE) For Examination of Mental Status
The Mini-Mental State Examination (MMSE) is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It examines functions including registration (repeating named prompts), attention and calculation, recall, language, ability to follow simple commands and orientation. Any score of 24 or more (out of 30) indicates a normal cognition.
Measured: Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startOct 2005
- Primary completionApr 2014
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TremorStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward Karst, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087046
- Sponsor's protocol ID
- C-04-02
- Status last verified
- Apr 2023
- First submitted
- 12 Mar 2014
- Last updated
- 25 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of the Advanced Neuromodulation System (ANS) Totally Implantable Deep Brain Stimulation System for the Suppression of Tremor in the Upper Extremities of Patients With Essential Tremor.
- ClinicalTrials.gov ID
- NCT02087046
- Acronym / sponsor ID
- C-04-02
- Conditions
- Tremor, Action Tremor, Essential Tremor, Tremor, Limb
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Apr 2014 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 14 Mar 2014 (estimated)
- Results
- Posted 26 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the proposed study is to demonstrate the safety and efficacy of the ANS Totally Implantable Deep Brain Stimulation System in the VIM nucleus of the thalamus implanted for the treatment of tremor due to essential tremor.
This study will be included in the Pre-Market Approval Application to support the safety of this device in use.
Detailed description
This study is designed as a prospective, multi-centered study for 365 days in duration from device implantation. A maximum of 12 sites will enroll 160 patients.
Each patient will be screened and then undergo a baseline evaluation followed by unilateral or bilateral implantation of the DBS system. During the implantation procedure, each patient will undergo a trial of stimulation in the operating room. The device may be internalized after a successful intra-operative trial or at a later surgery (no later than 4 weeks after initial lead placement). If the device is not activated immediately postsurgery, the patient may return to the clinic to determine optimum stimulation programming. Device programming will be optimized in as many visits as necessary following implantation. The day that the device is fully implanted will be classified as "Day 0" for each patient.
After "Day 0" the patient will return to clinic for evaluations at, Day 90 (±14 days), and Day 180 (±14 days) and Day 365 (approximately 12 months ± 30 days after Day 0). These evaluations consist of the CRST, the QUEST, the SF36, Patient and caregiver Global Ratings and the Patient Satisfaction Rating.
At Baseline and Day 180, the CRST evaluation session will be video recorded for analysis by an independent evaluator unaware of the functioning of the device. Additionally, at the Day 180 visit, the physician will have the option to provide the patient with amplitude control. A comparison of measures within the same person from pre-treatment to post-treatment will be performed. Also, pre-treatment and post-treatment group means and standard deviations will be determined.
Patients completed follow-up visits as part of the original protocol (C-04-02) for one year (or in some cases longer if patient was bilaterally implanted) and continued to complete additional visits as part of the Long-Term Follow-up protocol (C-06-03) for up to 5 years post implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stimulation | Other | Device: ANS Totally Implantable Deep Brain Stimulation SystemANS Totally Implantable Deep Brain Stimulation System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient or authorized representative has signed an informed consent.
- Patient is over 18 years of age.
- Patient is diagnosed with essential tremor for at least 3 years.
- Patient has a disabling medical-refractory upper extremity tremor with no evidence of supraspinal central nervous system disease or injury (tremor not adequately controlled by medications for at least three (3) months before implant).
- Patient has a postural or kinetic tremor severity score of at least 3 out of 4 in the extremity intended for treatment on the Fahn-Tolosa-Marin Clinical Rating Scale for Tremor.
Key exclusion criteria (17 listed)
- Patient is not surgical candidate;
- Patient has other clinically or medically significant disease;
- Patient has any neurological injury or disease other than essential tremor;
- Patient has any condition requiring repeated MRI scans;
- Patient has any condition requiring diathermy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANS Totally Implantable Deep Brain Stimulation SystemANS Totally Implantable Deep Brain Stimulation System will be implanted in the VIM nucleus of the thalamus | Device | Stimulation |
Primary outcome
Primary Efficacy Endpoint: Difference in the Postural Tremor Score of the Target Limb Between Stimulation On and Stimulation Off, As Assessed by the Blind Reviewer
Time frame: Day 180
The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.
Primary Safety Endpoint: Percentage of Participants With Device-related or Procedure Related Adverse Events
Time frame: Within 180 days following the initial implant
Percentage of device-related or procedure related adverse events will be assessed within 6 months following the initial unilateral implant. All such adverse events will be counted for 180 days following surgery or until the day of the second implant, which ever comes first.
65 secondary outcomes
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Target Limb Severity Score, As Assessed by the Site Physician
Time frame: Baseline
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Target Limb Severity Score, As Assessed by the Site Physician
Time frame: Day 90
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Target Limb Severity Score, As Assessed by the Site Physician
Time frame: Day 180
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Target Limb Severity Score, As Assessed by the Site Physician
Time frame: Day 365
Clinical Rating Scale for Tremor (CRST) Evaluation- Target Limb Responder Analysis, As Assessed by the Site Physician
Time frame: Day 90
Clinical Rating Scale for Tremor (CRST) Evaluation- Target Limb Responder Analysis, As Assessed by the Site Physician
Time frame: Day 180
Clinical Rating Scale for Tremor (CRST) Evaluation- Target Limb Responder Analysis, As Assessed by the Site Physician
Time frame: Day 365
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Handwriting for Target Side Severity Score, As Assessed by the Site Physician
Time frame: Baseline
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Handwriting for Target Side Severity Score, As Assessed by the Site Physician
Time frame: Day 90
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Handwriting for Target Side Severity Score, As Assessed by the Site Physician
Time frame: Day 180
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Handwriting for Target Side Severity Score, As Assessed by the Site Physician
Time frame: Day 365
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Handwriting for Target Side Severity Score, As Assessed by the Blind Reviewer
Time frame: Day 180
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Pouring From Target Side Severity Scores, As Assessed by the Site Physician
Time frame: Baseline
Clinical Rating Scale for Tremor (CRST) Evaluation-Mean Pouring From Target Side Severity Scores, As Assessed by the Site Physician
Time frame: Day 90
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Pouring From Target Side Severity Scores, As Assessed by the Site Physician
Time frame: Day 180
Clinical Rating Scale for Tremor (CRST) Evaluation-Mean Pouring From Target Side Severity Scores, As Assessed by the Site Physician
Time frame: Day 365
Clinical Rating Scale for Tremor (CRST) Evaluation- Pouring Ability From Target Side Severity Scores, As Assessed by the Blind Reviewer
Time frame: Day 180
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Total Motor Score, As Assessed by the Site Physician
Time frame: Baseline
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Total Motor Score, As Assessed by the Site Physician
Time frame: Day 90
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Total Motor Score, As Assessed by the Site Physician
Time frame: Day 180
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Total Motor Score, As Assessed by the Site Physician
Time frame: Day 365
Clinical Rating Scale for Tremor (CRST) Evaluation- Activity of Daily Living Score, As Assessed by the Site Physician
Time frame: Baseline
Clinical Rating Scale for Tremor (CRST) Evaluation- Activity of Daily Living Score, As Assessed by the Site Physician
Time frame: Day 90
Clinical Rating Scale for Tremor (CRST) Evaluation- Activity of Daily Living Score, As Assessed by the Site Physician
Time frame: Day 180
Clinical Rating Scale for Tremor (CRST) Evaluation- Activity of Daily Living Score, As Assessed by the Site Physician
Time frame: Day 365
Clinical Rating Scale for Tremor (CRST) Evaluation-Bilateral Stimulation, As Assessed by the Site Physician
Time frame: Baseline
Clinical Rating Scale for Tremor (CRST) Evaluation-Bilateral Stimulation, As Assessed by the Site Physician
Time frame: Following 180 days of stimulation
Clinical Rating Scale for Tremor (CRST) Evaluation-Non-Target Limb Severity Scores, As Assessed by the Site Physician
Time frame: Baseline
Clinical Rating Scale for Tremor (CRST) Evaluation-Non-Target Limb Severity Scores, As Assessed by the Site Physician
Time frame: Following 180 days of stimulation
Quality of Life in Essential Tremor (QUEST): Overall Summary Index
Time frame: Baseline
Change From Baseline for Quality of Life in Essential Tremor (QUEST): Overall Summary Index
Time frame: Day 90
Change From Baseline for Quality of Life in Essential Tremor (QUEST): Overall Summary Index
Time frame: Day 180
Change From Baseline for Quality of Life in Essential Tremor (QUEST): Overall Summary Index
Time frame: Day 365
SF36 Components and Individual Domains
Time frame: Baseline
SF36 Components and Individual Domains
Time frame: Day 90
SF36 Components and Individual Domains
Time frame: Day 180
SF36 Components and Individual Domains
Time frame: Day 365
Global Assessment Scores by Examiner
Time frame: Baseline
Global Assessment Scores by Examiner
Time frame: Day 90
Global Assessment Scores by Examiner
Time frame: Day 180
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Karst study director
Abbott
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ANS Totally Implantable Deep Brain Stimulation System in people with Tremor and Action Tremor, run by Abbott Medical Devices at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoint: Difference in the Postural Tremor Score of the Target Limb Between Stimulation On and Stimulation Off, As Assessed by the Blind Reviewer (time frame: Day 180). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.