An observational study in Severe Disabling Tremor, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Assistance Publique Hopitaux De Marseille · Observational
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 Ess…PubMed 39168114 ↗
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 :
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.
158 studies on the registry are indexed under Tremor; 44 are open to participants now.
This study's enrollment of 700 is above the median of 74 across 45 observational studies indexed under Tremor.
Browse Tremor studies →Assistance Publique Hopitaux De Marseille is the lead sponsor of 702 studies on the registry; 139 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with severe tremor (Essential Tremor type, Parkinson's disease tremor or others) responsible for significant functional impairment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Collection of non-genetic, chronobiological, therapeutic and co-morbidities
Device: gamma knife radiosurgery
The surgical procedure consists of a very partial radiation of the brain with a stereotactic precision performed in current practice
Clinical evaluation of tremor reduction in relation to clinical co-morbidity
Clinical response increases with decrease in clinical co-morbidity
Time frame: 12 months
Plan to share: Undecided
Ran from Oct 2017 to primary completion in Dec 2019, 26 months.
Primary completion moved twice since we started tracking on Sep 25, 2026: Oct 2021 → Dec 2019, last on Oct 26, 2026.
Completion moved once since we started tracking on Sep 25, 2026: Oct 2021 → Sep 2021, on Oct 20, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
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 Ess…PubMed 39168114 ↗
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 Ess…PubMed 39168114 ↗
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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