Multiple SclerosisGK-SEPNCT03339908
Regional Non-comparative Prospective Study of the Impact of Gamma Knife Radiosurgery on Tremor in Multiple Sclerosis
A study testing Thalamotomy by gamma Knife radiosurgery in people with Multiple Sclerosis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Multiple sclerosis, chronic inflammatory disease of the central nervous system, affects approximately 100,000 peoples in France. It is the leading cause of disability in young adults. Tremor is a common symptom (25-58% of patients depending on the series) and can be particularly disabling. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Thalamotomy by gamma Knife radiosurgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 23 Oct 2017to 4 Apr 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 to 70 years old.
- Patient with a diagnosis of MS certainty according to the criteria of Mac Donald (2010)
- Patient with progressive form of MS: remitting, secondarily progressive, primary progressive
- Patient with an Expanded Disability Status Scale score (EDSS) between 3 and 8.
- Patient with clinical stability for more than 6 months (EDSS stable over 1 year)
- Lack of progressive onset (and corticosteroid therapy) for at least 3 months
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- Patient with normal palliation or mild impairment
- Patient having a muscle test at 4 or 5 on the upper limb to be treated
- Patient requiring Gamma-Knife radiosurgery due to severity of tremor and functional impairment
- Patient who understood and signed the informed consent form
Who cannot join
- Stewart Holmes positive maneuver (upper limb to be treated)
- Patient with a muscle test less than 4 on the hand to be treated
- Patient with moderate palliation or severe disease
- Patient with a contraindication to perform a cerebral MRI (pacemaker, intracerebral metallic object etc.)
- Patient with an indication for radiosurgical treatment
- Pregnant or lactating women.
- Participation in another therapeutic trial or exclusion period from a previous clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Multiple sclerosis, chronic inflammatory disease of the central nervous system, affects approximately 100,000 peoples in France. It is the leading cause of disability in young adults. Tremor is a common symptom (25-58% of patients depending on the series) and can be particularly disabling. The drug treatments against tremor are ineffective or insufficient. Deep brain stimulation of the Vim (Small nucleus within thalamus) and stereotactic radiofrequency thalamotomy have shown their efficacy in this indication. However, in some cases these invasive procedures are impossible because of operational risk. Gamma knife thalamotomy can be an alternative choice. This procedure, less invasive, mainly because of the absence of craniotomy is used by several teams of international reputation for over fifteen years, with good to excellent results in essential tremor. The team of Marseille, which has an experience of 22 years in Gamma Knife radiosurgery has treated 250 patients with severe tremor (essential tremor or Parkinson's disease) by a unilateral thalamotomy with an improvement of 70% of functional scores.
In the literature, no formal studies of the effect of Gamma Knife in Multiple Sclerosis (MS) tremor is reported. There are only a few cases without specific evaluation of the efficacy in this disease. Hence the importance of studying in detail the effects of this technique, which allows a precise and limited lesion volume. Using an isocenter of 4mm and a dose of 130 Gy radiation lesion obtained is limited to a volume of 200 to 500 mm3.
Read more
The aim of this study is to assess through a minimally invasive technique with a circumscribed and reproducible lesion volume, the effect of thalamotomy on the particular tremor in multiple sclerosis with a prospective evaluation of its effects.
Patients with MS with a disabling tremor will be included in the study. They will be assessed with neurological examination, quality of life scales, neuropsychological assessment, functional scores and cerebral MRI.
This study will demonstrate the feasibility and effectiveness of Gamma Knife thalamotomy in MS patients with severe tremor.
- Conditions
- Multiple Sclerosis
- Being tested
- Thalamotomy by gamma Knife radiosurgery
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thalamotomy by gamma Knife radiosurgeryDevice
The surgical procedure consists of a very partial radiation of the brain with stereotaxic precision
| Study group | Role | What they receive |
|---|---|---|
| patients with Multiple Sclerosis | Experimental | Patients will benefit from unilateral thalamotomy by Gamma Knife radiosurgery Receives: Device: Thalamotomy by gamma Knife radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale evaluation Tremor and Coordination Scale (TACS)
Describe the effectiveness of the Gamma Knife radiosurgical treatment. Assess the impact of tremor and impaired coordination on daily activities. The TACS was developed as a single question, scored ordinally from 0 to 5, as follows: 0 (normal), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (total disability). This scoring system makes it similar to the Performance Scales
Measured: 12 months
Scale evaluation Tremor and Coordination Scale (TACS)
Describe the effectiveness of the Gamma Knife radiosurgical treatment. Assess the impact of tremor and impaired coordination on daily activities. The TACS was developed as a single question, scored ordinally from 0 to 5, as follows: 0 (normal), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (total disability). This scoring system makes it similar to the Performance Scales
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start23 Oct 2017
- Primary completion20 Jan 2021
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Marie REGIS, PU-PH, Principal investigator, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339908
- Sponsor's protocol ID
- 2016-22
- Other IDs
- 2016-A01071-50
- Acronym
- GK-SEP
- Status last verified
- Apr 2023
- First submitted
- 8 Nov 2017
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Non-comparative Prospective Study of the Impact of Gamma Knife Radiosurgery on Tremor in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03339908
- Acronym / sponsor ID
- GK-SEP / 2016-22
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 13 Nov 2017 (actual)
- 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.
Multiple sclerosis, chronic inflammatory disease of the central nervous system, affects approximately 100,000 peoples in France. It is the leading cause of disability in young adults. Tremor is a common symptom (25-58% of patients depending on the series) and can be particularly disabling. The drug treatments against tremor are ineffective or insufficient. Deep brain stimulation of the Vim (Small nucleus within thalamus) and stereotactic radiofrequency thalamotomy have shown their efficacy in this indication. However, in some cases these invasive procedures are impossible because of operational risk. Gamma knife thalamotomy can be an alternative choice. This procedure, less invasive, mainly because of the absence of craniotomy is used by several teams of international reputation for over fifteen years, with good to excellent results in essential tremor. The team of Marseille, which has an experience of 22 years in Gamma Knife radiosurgery has treated 250 patients with severe tremor (essential tremor or Parkinson's disease) by a unilateral thalamotomy with an improvement of 70% of functional scores.
In the literature, no formal studies of the effect of Gamma Knife in Multiple Sclerosis (MS) tremor is reported. There are only a few cases without specific evaluation of the efficacy in this disease. Hence the importance of studying in detail the effects of this technique, which allows a precise and limited lesion volume. Using an isocenter of 4mm and a dose of 130 Gy radiation lesion obtained is limited to a volume of 200 to 500 mm3.
The aim of this study is to assess through a minimally invasive technique with a circumscribed and reproducible lesion volume, the effect of thalamotomy on the particular tremor in multiple sclerosis with a prospective evaluation of its effects.
Patients with MS with a disabling tremor will be included in the study. They will be assessed with neurological examination, quality of life scales, neuropsychological assessment, functional scores and cerebral MRI.
This study will demonstrate the feasibility and effectiveness of Gamma Knife thalamotomy in MS patients with severe tremor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with Multiple Sclerosis | Experimental | Device: Thalamotomy by gamma Knife radiosurgeryPatients will benefit from unilateral thalamotomy by Gamma Knife radiosurgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female aged 18 to 70 years old.
- Patient with a diagnosis of MS certainty according to the criteria of Mac Donald (2010)
- Patient with progressive form of MS: remitting, secondarily progressive, primary progressive
- Patient with an Expanded Disability Status Scale score (EDSS) between 3 and 8.
- Patient with clinical stability for more than 6 months (EDSS stable over 1 year)
Key exclusion criteria (7 listed)
- Stewart Holmes positive maneuver (upper limb to be treated)
- Patient with a muscle test less than 4 on the hand to be treated
- Patient with moderate palliation or severe disease
- Patient with a contraindication to perform a cerebral MRI (pacemaker, intracerebral metallic object etc.)
- Patient with an indication for radiosurgical treatment
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 |
|---|---|---|
| Thalamotomy by gamma Knife radiosurgeryThe surgical procedure consists of a very partial radiation of the brain with stereotaxic precision | Device | patients with Multiple Sclerosis |
Primary outcome
Scale evaluation Tremor and Coordination Scale (TACS)
Time frame: 12 months
Describe the effectiveness of the Gamma Knife radiosurgical treatment. Assess the impact of tremor and impaired coordination on daily activities. The TACS was developed as a single question, scored ordinally from 0 to 5, as follows: 0 (normal), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (total disability). This scoring system makes it similar to the Performance Scales
Scale evaluation Tremor and Coordination Scale (TACS)
Time frame: 24 months
Describe the effectiveness of the Gamma Knife radiosurgical treatment. Assess the impact of tremor and impaired coordination on daily activities. The TACS was developed as a single question, scored ordinally from 0 to 5, as follows: 0 (normal), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (total disability). This scoring system makes it similar to the Performance Scales
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 6 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
Jean-Marie REGIS, PU-PH principal investigator
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thalamotomy by gamma Knife radiosurgery in people with Multiple Sclerosis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 10 inclusion and 7 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 6 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 1 site in France. 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?
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?
Scale evaluation Tremor and Coordination Scale (TACS) (time frame: 12 months). 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 6 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.