Essential TremorNCT02255929
Gamma Knife Radiosurgery for Treatment of Essential Tremor
A study testing Gamma Knife Radiosurgery in people with Essential Tremor, run by Swedish Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to examine effects (good and bad) of gamma knife radiosurgery for essential tremor. The gamma knife places a small lesion in the brain to suppress tremors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Tremor
- What is being tested?
- Gamma Knife Radiosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women age 18 years or older
- Diagnosis of essential tremor as confirmed from clinical history and examination by a neurologist or neurosurgeon
- Tremor following prior first line therapy with either propranolol or primidone
- Must be able to undergo MRI of brain and CT of head for treatment planning
- Postural or intention tremor severity score of greater than or equal to 2 in one hand/arm as measured by the CRST rating scale
Who cannot join
- Prior ipsilateral stereotactic radiosurgical ablation of the thalamus, ipsilateral deep brain stimulation, radiofrequency ablation of a ipsilateral thalamic target, or ultrasound ablation of an ipsilateral thalamic target
- Prior whole brain radiation therapy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Swedish Medical Center Radiosurgery Center
Seattle, Washington, 98122
About this study
Official title: Gamma Knife Thalamotomy for Treatment of Essential Tremor
The purpose of this study is to examine effects (good and bad) of gamma knife radiosurgery for essential tremor. The gamma knife places a small lesion in the brain to suppress tremors.
Read the detailed description
This research is being done because although multiple studies evaluating gamma knife for essential tremor show good results, few studies evaluating patients prospectively have been done. Prior studies have looked at patient outcomes following treatment - also known as retrospective studies. In this study, data collection will initiate before treatment, to obtain consistent baseline evaluations from all study participants undergoing the gamma knife treatment and at specific intervals following treatment.
- Conditions
- Essential Tremor
- Being tested
- Gamma Knife Radiosurgery
- Keywords
- Benign Essential Tremor, Tremor, Neurologic Manifestations, Nervous System Diseases, Movement Disorders, Central Nervous System Diseases
- Medical subject headings
- Essential Tremor, Tremor, Neurologic Manifestations, Nervous System Diseases, Movement Disorders, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamma Knife RadiosurgeryRadiation
| Study group | Role | What they receive |
|---|---|---|
| Gamma Knife Radiosurgery | Experimental | Gamma Knife treatment is conducted in one day and takes approximately 70 to 90 minutes. Receives: Radiation: Gamma Knife Radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Effectiveness based on Clinical Rating Scale for Tumor (CRST-Part B) questionnaires.
The change observed is represented by a writing and drawing score assessment of tremors. The assessment is conducted by a movement disorder neurologist in a blinded fashion.
Measured: Baseline, 6, 12, 24, and 36 Months Post Treatment
Secondary outcomes (1)
Safety Based on the Number of Incidences and Severity of Adverse Events Related with Gamma Knife Thalamotomy
Adverse Events to be reported as mild, moderate or severe
Measured: Baseline, 6, 12, 24, and 36 Months Post Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- 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
- 183 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swedish Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Loiselle, MD, Principal investigator, Swedish Medical Center Radiosurgery Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255929
- Sponsor's protocol ID
- IR 5585
- Status last verified
- Jan 2023
- First submitted
- 17 Sep 2014
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gamma Knife Thalamotomy for Treatment of Essential Tremor
- ClinicalTrials.gov ID
- NCT02255929
- Acronym / sponsor ID
- IR 5585
- Conditions
- Essential Tremor
- Keywords
- Benign Essential Tremor, Tremor, Neurologic Manifestations, Nervous System Diseases, Movement Disorders, Central Nervous System Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 183 participants (estimated)
- Lead sponsor
- Swedish Medical CenterUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 3 Oct 2014 (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 examine effects (good and bad) of gamma knife radiosurgery for essential tremor. The gamma knife places a small lesion in the brain to suppress tremors.
Detailed description
This research is being done because although multiple studies evaluating gamma knife for essential tremor show good results, few studies evaluating patients prospectively have been done. Prior studies have looked at patient outcomes following treatment - also known as retrospective studies. In this study, data collection will initiate before treatment, to obtain consistent baseline evaluations from all study participants undergoing the gamma knife treatment and at specific intervals following treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gamma Knife Radiosurgery | Experimental | Radiation: Gamma Knife RadiosurgeryGamma Knife treatment is conducted in one day and takes approximately 70 to 90 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women age 18 years or older
- Diagnosis of essential tremor as confirmed from clinical history and examination by a neurologist or neurosurgeon
- Tremor following prior first line therapy with either propranolol or primidone
- Must be able to undergo MRI of brain and CT of head for treatment planning
- Postural or intention tremor severity score of greater than or equal to 2 in one hand/arm as measured by the CRST rating scale
Key exclusion criteria (3 listed)
- Prior ipsilateral stereotactic radiosurgical ablation of the thalamus, ipsilateral deep brain stimulation, radiofrequency ablation of a ipsilateral thalamic target, or ultrasound ablation of an ipsilateral thalamic target
- Prior whole brain radiation therapy
- Pregnancy
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 |
|---|---|---|
| Gamma Knife Radiosurgery | Radiation | Gamma Knife Radiosurgery |
Primary outcome
Change in Effectiveness based on Clinical Rating Scale for Tumor (CRST-Part B) questionnaires.
Time frame: Baseline, 6, 12, 24, and 36 Months Post Treatment
The change observed is represented by a writing and drawing score assessment of tremors. The assessment is conducted by a movement disorder neurologist in a blinded fashion.
1 secondary outcome
Safety Based on the Number of Incidences and Severity of Adverse Events Related with Gamma Knife Thalamotomy
Time frame: Baseline, 6, 12, 24, and 36 Months Post Treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Click here for more information about the Swedish Medical Center Radiosurgery CenterLink 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.
Christopher Loiselle, MD principal investigator
Swedish Medical Center Radiosurgery Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamma Knife Radiosurgery in people with Essential Tremor, run by Swedish Medical Center at 1 site 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Change in Effectiveness based on Clinical Rating Scale for Tumor (CRST-Part B) questionnaires. (time frame: Baseline, 6, 12, 24, and 36 Months Post Treatment). 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 23 Jan 2023.