Parkinson DiseaseNCT00552474
Deep Brain Stimulation to Treat Symptoms of Parkinson's Disease
A study testing Libra Deep Brain Stimulation System in people with Parkinson Disease and Movement Disorders, run by Abbott Medical Devices at 15 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of bilateral stimulation of the subthalamic nucleus (STN) of the brain when using the ANS Totally Implantable Deep Brain Stimulation System as an adjunctive treatment for reducing some of the symptoms of Parkinson's Disease that are not adequately… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease, Movement Disorders
- What is being tested?
- Libra Deep Brain Stimulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 15 sitesUnited States
- Study dates
- Oct 2005to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Person is 18 to 80 years of age
- Person has been diagnosed with Parkinson's disease for at lease five (5) years
- Person experiences at least six (6) hours or more daily "off-time" or moderate to severe dyskinesias during waking hours
- Person has a history of improvement of Parkinson's symptoms with l-dopa (levodopa) therapy
- Person must be willing to maintain a constant dose of anti-Parkinson's disease medication for at least one month prior to study enrollment
- Person must be available for appropriate follow-up times for the length of the study
Who cannot join
- Person has any major illness or medical condition that would interfere with participation in the study
- Person currently suffers from untreated, major depression
- Person has an electrical or electromagnetic implant (e.g. cochlear prosthesis or pacemaker)
- Person has had a prior surgery for the treatment of PD symptoms, including previous DBS surgery
- Person has dementia
- Person has a history of seizures
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Lahey Clinic
Burlington, Massachusetts, 01805
Univerisity of Virginia
Charlottesville, Virginia, 22903
Rush University Medical Center
Chicago, Illinois, 60612
Mayfield Clinic
Cincinnati, Ohio, 45267
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
Loma Linda University School of Medicine
Loma Linda, California, 92354
Universtiy of Miami
Miami, Florida, 33136
Medical College of Wisconcin
Milwaukee, Wisconsin, 53226
Mount Sinai School of Medicine
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
Pennsylvania Hospital (UPHS)
Philadelphia, Pennsylvania, 19107
University of Rochester
Rochester, New York, 14618
About this study
Official title: A Clinical Evaluation of Bilateral Stimulation of the Subthalamic Nucleus (STN) Using the ANS Totally Implantable Deep Brain Stimulation System as an Adjunctive Treatment for Reducing Some of the Symptoms of Advanced, Levodopa-responsive Parkinson's Disease That Are Not Adequately Controlled With Medication.
The purpose of this study is to evaluate the safety and efficacy of bilateral stimulation of the subthalamic nucleus (STN) of the brain when using the ANS Totally Implantable Deep Brain Stimulation System as an adjunctive treatment for reducing some of the symptoms of Parkinson's Disease that are not adequately controlled with medication.
Read the detailed description
This is a prospective, controlled, multi-centered, 12 months post-implantation study. A maximum of 15 sites will enroll a total of 136 patients.
All study participants will have the study device surgically implanted. After implant surgery, study participants will return to the clinic for evaluation 30 days after surgery, three months after surgery, six months after surgery and twelve months after surgery. At the baseline, three, six and twelve month visits the patient's Parkinson's symptoms and ability to perform daily activities will be evaluated using a number of accepted assessment tools including a Dyskinesia diary, evaluation of PD symptoms, quality of life scoring and patient extension study to monitor the safety and efficacy of the ANS Libra/Libra Deep Brain Stimulation System.
After the 1 year study, patients may enter another protocol (C-06-04) to continue to monitor the safety and efficacy of the Libra Deep Brain Stimulation System. Patients may be followed for an additional 4 years.
If necessary, patients may continue to have access to the investigational device under protocol (C-13-02) which allows for compassionate use access to it.
- Conditions
- Parkinson Disease, Movement Disorders
- Being tested
- Libra Deep Brain Stimulation System
- Keywords
- Parkinson disease, Movement disorders, Deep Brain Stimulation, Libra, l-dopa, levodopa, neuromodulation, neurostimulation, Electrical stimulation of the brain, STN, Subthalamic nucleus
- Medical subject headings
- Parkinson Disease, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Libra Deep Brain Stimulation SystemDevice
Active DBS Therapy
Libra Deep Brain Stimulation SystemDevice
Implanted system but no stimulation
| Study group | Role | What they receive |
|---|---|---|
| Group B | Placebo comparator | Implanted but no active stimulation Receives: Device: Libra Deep Brain Stimulation System |
| Group A | Experimental | Active Stimulation Receives: Device: Libra Deep Brain Stimulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase the duration of "on time" without dyskinesias or with non-bothersome dyskinesias
Measured: 90 days
Secondary outcomes (1)
Changes in the following over time: Incidence of AEs; UPDRS motor scores; Activities of Daily Living; Quality of Life, Quality Sleep Index, Hoehn and Yahr Staging, Global Outcome evaluation and Patient Satisfaction
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2007 (estimated)
- Study startOct 2005
- Primary completionOct 2010
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- DeLea Peichel, Study director, ANS/St Jude Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552474
- Sponsor's protocol ID
- C-04-01
- Status last verified
- Jan 2019
- First submitted
- 31 Oct 2007
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Okun MS, Gallo BV, Mandybur G, Jagid J, Foote KD, Revilla FJ, Alterman R, Jankovic J, Simpson R, Junn F, Verhagen L, Arle JE, Ford B, Goodman RR, Stewart RM, Horn S, Baltuch GH, Kopell BH, Marshall F, Peichel D, Pahwa R, Lyons KE, Troster AI, Vitek JL, Tagliati M; SJM DBS Study Group. Subthalamic deep brain stimulation with a constant-current device in Parkinson's disease: an open-label randomised controlled trial. Lancet Neurol. 2012 Feb;11(2):140-9. doi: 10.1016/S1474-4422(11)70308-8. Epub 2012 Jan 11.
PubMed 22239915
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of Bilateral Stimulation of the Subthalamic Nucleus (STN) Using the ANS Totally Implantable Deep Brain Stimulation System as an Adjunctive Treatment for Reducing Some of the Symptoms of Advanced, Levodopa-responsive Parkinson's Disease That Are Not Adequately Controlled With Medication.
- ClinicalTrials.gov ID
- NCT00552474
- Acronym / sponsor ID
- C-04-01
- Conditions
- Parkinson Disease, Movement Disorders
- Keywords
- Parkinson disease, Movement disorders, Deep Brain Stimulation, Libra, l-dopa, levodopa, neuromodulation, neurostimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Oct 2010 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 2 Nov 2007 (estimated)
- Results
- Not posted in the source record
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 this study is to evaluate the safety and efficacy of bilateral stimulation of the subthalamic nucleus (STN) of the brain when using the ANS Totally Implantable Deep Brain Stimulation System as an adjunctive treatment for reducing some of the symptoms of Parkinson's Disease that are not adequately controlled with medication.
Detailed description
This is a prospective, controlled, multi-centered, 12 months post-implantation study. A maximum of 15 sites will enroll a total of 136 patients.
All study participants will have the study device surgically implanted. After implant surgery, study participants will return to the clinic for evaluation 30 days after surgery, three months after surgery, six months after surgery and twelve months after surgery. At the baseline, three, six and twelve month visits the patient's Parkinson's symptoms and ability to perform daily activities will be evaluated using a number of accepted assessment tools including a Dyskinesia diary, evaluation of PD symptoms, quality of life scoring and patient extension study to monitor the safety and efficacy of the ANS Libra/Libra Deep Brain Stimulation System.
After the 1 year study, patients may enter another protocol (C-06-04) to continue to monitor the safety and efficacy of the Libra Deep Brain Stimulation System. Patients may be followed for an additional 4 years.
If necessary, patients may continue to have access to the investigational device under protocol (C-13-02) which allows for compassionate use access to it.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group B | Placebo comparator | Device: Libra Deep Brain Stimulation SystemImplanted but no active stimulation |
| Group A | Experimental | Device: Libra Deep Brain Stimulation SystemActive Stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Person is 18 to 80 years of age
- Person has been diagnosed with Parkinson's disease for at lease five (5) years
- Person experiences at least six (6) hours or more daily "off-time" or moderate to severe dyskinesias during waking hours
- Person has a history of improvement of Parkinson's symptoms with l-dopa (levodopa) therapy
- Person must be willing to maintain a constant dose of anti-Parkinson's disease medication for at least one month prior to study enrollment
Key exclusion criteria (6 listed)
- Person has any major illness or medical condition that would interfere with participation in the study
- Person currently suffers from untreated, major depression
- Person has an electrical or electromagnetic implant (e.g. cochlear prosthesis or pacemaker)
- Person has had a prior surgery for the treatment of PD symptoms, including previous DBS surgery
- Person has dementia
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 |
|---|---|---|
| Libra Deep Brain Stimulation SystemActive DBS Therapy | Device | Group A |
| Libra Deep Brain Stimulation SystemImplanted system but no stimulation | Device | Group B |
Primary outcome
Increase the duration of "on time" without dyskinesias or with non-bothersome dyskinesias
Time frame: 90 days
1 secondary outcome
Changes in the following over time: Incidence of AEs; UPDRS motor scores; Activities of Daily Living; Quality of Life, Quality Sleep Index, Hoehn and Yahr Staging, Global Outcome evaluation and Patient Satisfaction
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Derived from this study: PubMed 22239915Okun MS, Gallo BV, Mandybur G, Jagid J, Foote KD, Revilla FJ, Alterman R, Jankovic J, Simpson R, Junn F, Verhagen L, Arle JE, Ford B, Goodman RR, Stewart RM, Horn S, Baltuch GH, Kopell BH, Marshall F, Peichel D, Pahwa R, Lyons KE, Troster AI, Vitek JL, Tagliati M; SJM DBS Study Group. Subthalamic deep brain stimulation with a constant-current device in Parkinson's disease: an open-label randomised controlled trial. Lancet Neurol. 2012 Feb;11(2):140-9. doi: 10.1016/S1474-4422(11)70308-8. Epub 2012 Jan 11.
- ANS specific websiteLink provided by the sponsor.
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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.
DeLea Peichel study director
ANS/St Jude Medical
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Libra Deep Brain Stimulation System in people with Parkinson Disease and Movement Disorders, run by Abbott Medical Devices at 15 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 6 inclusion and 6 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 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Increase the duration of "on time" without dyskinesias or with non-bothersome dyskinesias (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00552474, which also lists 1 linked publication.
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 4 Feb 2019.