Severe Disabling TremorGARPNCT03350139
Evaluation of the Predictors of Clinical and Radiological Response to Gamma-Knife Radiosurgery in the Treatment of Intermediate Ventral Nucleus of the Thalamus (VIM) Thalamotomy Tremor.
An observational study of Severe Disabling Tremor, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Gamma-Knife radiosurgery of the VIM for patients presenting with severe drug-resistant tremor is now current practice as an alternative to Deep Brain Stimulation (DBS) of the VIM. Now, around 100 patients are treated annually in our unit (essential tremor or Parkinson tremor). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Severe Disabling Tremor
- What is being tested?
- gamma knife radiosurgery
- Type of treatment
- Medical device
- How many people
- 700 participants
- Where
- 1 siteFrance
- Study dates
- 25 Oct 2017to 15 Sep 2021
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe tremor (Essential Tremor type, Parkinson's disease tremor or others) responsible for significant functional impairment.
Who may be able to join
- Male or female aged 20 years minimum
- Patient with absolute contraindication or relative to deep brain stimulation (DBS) of VIM.
- Patient having the Gamma Knife radiosurgery of VIM (combining clinical and paraclinical conditions).
- Patient affiliated to a social security scheme.
- Patient having understood and signed the information notice for non opposition.
Who cannot join
- Patient having a contraindication to performing a cerebral MRI (pace-maker, intracerebral metallic object etc.)
- Patient with a contraindication to radiosurgical treatment (previous treatment with cerebral radiotherapy)
- Vulnerable persons: minors, protected adults (guardianship or trusteeship) and adults unable to express their non-opposition.
Trial locations and contacts
1 site in 1 country.
About this study
Gamma-Knife radiosurgery of the VIM for patients presenting with severe drug-resistant tremor is now current practice as an alternative to Deep Brain Stimulation (DBS) of the VIM.
Now, around 100 patients are treated annually in our unit (essential tremor or Parkinson tremor).
Read more
Clinical and radiological follow-up is demonstrating that 80% of these patients are presenting with a homogenous response complete or subtotal, the disappearance of the tremor mean delay of 6 months after radiosurgery. In neuroradiological responses on the MRI, is appearing roughly at the same time local contrast enhancement surrounding highty to signal no associated with clinical side effects.
In 15 to 20% of the patients, the clinical effets is not obtained and in the vast majority no MRI response or minimal MRI response is observed on images suggesting that these failures are related to specific resistance to radiosurgery of this subgroup.
In roughly 5% of the patients, at the contrary, hyper response is observe on the MRI rating clinically with side effects (hemiparesis or proprioceptive ataxia or dysarthria, hands problems….). The adverse effects are generally reversible either in whole or in part with the resorption of the perilesionnel oedema.
It would be extremely helpfull to be able to identify in advance these 2 groups of hyper and hypo respondeurs.
The capacity to identify in advance these patients at risk to hypo or hyper response would allow us to either contre-indicate radiosurgery or modify radiosurgery technicaly at the time of dose planing.
Sequently, these predictions would allow us to tailor individually mission management and information leading to improvment of the efficacy and tolerance of this kind of intervention.
The parameters suspected to be likely to influence the response are :
- genetics
- co-morbidities (diabetis, vascular…)
- Main aspect of the brain (severe atrophy, vascular, micro-infacts…)
- Chronobiological (timing during the day of the radiosurgical procedure)
- Associated medication (potential radioprotector or radiosensitizer effect of some drugs)
- Radiobiological (dose rate…)
The goal of this study is to collect all of these informations out of genetical one in the cohort of 700 patients having benefited ou will benefit from radiosurgery in the situation for essential tremor and parkinson disease. It will be test the predictive value of these parameters and the capacity to predict hyper or hypo response.
The work on the genetic material will take place in the second stage in the frame of a new different resarch project.
- Conditions
- Severe Disabling Tremor
- Being tested
- gamma knife radiosurgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gamma knife radiosurgeryDevice
The surgical procedure consists of a very partial radiation of the brain with a stereotactic precision performed in current practice
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with gamma knife radiosurgery | Collection of non-genetic, chronobiological, therapeutic and co-morbidities Receives: Device: gamma knife radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation of tremor reduction in relation to clinical co-morbidity
Clinical response increases with decrease in clinical co-morbidity
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start25 Oct 2017
- Primary completion31 Dec 2019
- Study completion15 Sep 2021
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 Severe Disabling TremorStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Olivier ARNAUD, General Director, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03350139
- Sponsor's protocol ID
- 2017-09
- Other IDs
- ID RCB
- Acronym
- GARP
- Status last verified
- Oct 2026
- First submitted
- 16 Nov 2017
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mira V, Zwaard B, Boutin E, Guillaud E, Cretol A, Regis J, Azulay JP, Witjas T, Vaugoyeau M. Effects on Gait and Balance of VIM Gamma Knife Radiosurgery in Essential Tremor. Stereotact Funct Neurosurg. 2024;102(5):284-292. doi: 10.1159/000539812. Epub 2024 Aug 21.
PubMed 39168114
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Predictors of Clinical and Radiological Response to Gamma-Knife Radiosurgery in the Treatment of Intermediate Ventral Nucleus of the Thalamus (VIM) Thalamotomy Tremor.
- ClinicalTrials.gov ID
- NCT03350139
- Acronym / sponsor ID
- GARP / 2017-09
- Conditions
- Severe Disabling Tremor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 22 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.
Gamma-Knife radiosurgery of the VIM for patients presenting with severe drug-resistant tremor is now current practice as an alternative to Deep Brain Stimulation (DBS) of the VIM.
Now, around 100 patients are treated annually in our unit (essential tremor or Parkinson tremor).
Clinical and radiological follow-up is demonstrating that 80% of these patients are presenting with a homogenous response complete or subtotal, the disappearance of the tremor mean delay of 6 months after radiosurgery. In neuroradiological responses on the MRI, is appearing roughly at the same time local contrast enhancement surrounding highty to signal no associated with clinical side effects.
In 15 to 20% of the patients, the clinical effets is not obtained and in the vast majority no MRI response or minimal MRI response is observed on images suggesting that these failures are related to specific resistance to radiosurgery of this subgroup.
In roughly 5% of the patients, at the contrary, hyper response is observe on the MRI rating clinically with side effects (hemiparesis or proprioceptive ataxia or dysarthria, hands problems….). The adverse effects are generally reversible either in whole or in part with the resorption of the perilesionnel oedema.
It would be extremely helpfull to be able to identify in advance these 2 groups of hyper and hypo respondeurs.
The capacity to identify in advance these patients at risk to hypo or hyper response would allow us to either contre-indicate radiosurgery or modify radiosurgery technicaly at the time of dose planing.
Sequently, these predictions would allow us to tailor individually mission management and information leading to improvment of the efficacy and tolerance of this kind of intervention.
The parameters suspected to be likely to influence the response are :
- genetics
- co-morbidities (diabetis, vascular…)
- Main aspect of the brain (severe atrophy, vascular, micro-infacts…)
- Chronobiological (timing during the day of the radiosurgical procedure)
- Associated medication (potential radioprotector or radiosensitizer effect of some drugs)
- Radiobiological (dose rate…)
The goal of this study is to collect all of these informations out of genetical one in the cohort of 700 patients having benefited ou will benefit from radiosurgery in the situation for essential tremor and parkinson disease. It will be test the predictive value of these parameters and the capacity to predict hyper or hypo response.
The work on the genetic material will take place in the second stage in the frame of a new different resarch project.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with gamma knife radiosurgery | – | Device: gamma knife radiosurgeryCollection of non-genetic, chronobiological, therapeutic and co-morbidities |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe tremor (Essential Tremor type, Parkinson's disease tremor or others) responsible for significant functional impairment.
Key inclusion criteria (5 listed)
- Male or female aged 20 years minimum
- Patient with absolute contraindication or relative to deep brain stimulation (DBS) of VIM.
- Patient having the Gamma Knife radiosurgery of VIM (combining clinical and paraclinical conditions).
- Patient affiliated to a social security scheme.
- Patient having understood and signed the information notice for non opposition.
Key exclusion criteria (3 listed)
- Patient having a contraindication to performing a cerebral MRI (pace-maker, intracerebral metallic object etc.)
- Patient with a contraindication to radiosurgical treatment (previous treatment with cerebral radiotherapy)
- Vulnerable persons: minors, protected adults (guardianship or trusteeship) and adults unable to express their non-opposition.
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 radiosurgeryThe surgical procedure consists of a very partial radiation of the brain with a stereotactic precision performed in current practice | Device | Patients treated with gamma knife radiosurgery |
Primary outcome
Clinical evaluation of tremor reduction in relation to clinical co-morbidity
Time frame: 12 months
Clinical response increases with decrease in clinical co-morbidity
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 26 Oct 2026.
- Results publication: PubMed 39168114Mira V, Zwaard B, Boutin E, Guillaud E, Cretol A, Regis J, Azulay JP, Witjas T, Vaugoyeau M. Effects on Gait and Balance of VIM Gamma Knife Radiosurgery in Essential Tremor. Stereotact Funct Neurosurg. 2024;102(5):284-292. doi: 10.1159/000539812. Epub 2024 Aug 21.
- Individual participant dataSharing planned: Undecided
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-Olivier ARNAUD, General Director study director
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?
An observational study of Severe Disabling Tremor, 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 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: finished, as of the sponsor's last update on 26 Oct 2026. 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?
Clinical evaluation of tremor reduction in relation to clinical co-morbidity (time frame: 12 months). 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 NCT03350139, 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 26 Oct 2026.