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CompletedNCT03350139GARPUpdated Oct 26, 2026

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 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

Updated Oct 26, 2026Now CompletedResults publication added+4 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
700
Ages
20 Years and older
Sex
All
01

Study 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).

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.

02

Conditions studied

  • Severe Disabling Tremor

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03

In context

Tremor

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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.

Inclusion criteria

  • Male or female aged 20 years minimum
  • Patient with absolute 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.

Exclusion criteria

Exclusion Criteria:

  • Patient having a 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.
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
700 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients treated with gamma knife radiosurgery

    Collection of non-genetic, chronobiological, therapeutic and co-morbidities

    Device: gamma knife radiosurgery

Interventions

  • Devicegamma knife radiosurgery

    The surgical procedure consists of a very partial radiation of the brain with a stereotactic precision performed in current practice

06

What researchers measure

Primary outcomes

  1. Clinical evaluation of tremor reduction in relation to clinical co-morbidity

    Clinical response increases with decrease in clinical co-morbidity

    Time frame: 12 months

07

Study locations

1 site
  • Assistance Publique Hôpitaux de Marseille
    Marseille, 13354, France
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

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.

Registered
Nov 16, 2017
First posted
Nov 22, 2017
StartActual
Oct 25, 2017
Primary completionActual
Dec 31, 2019was Oct 2021
CompletionActual
Sep 15, 2021was Oct 2021
Last update
Oct 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Status unknown→Completed
changed Oct 20, 2026
Start date
Oct 23, 2017→Oct 25, 2017
Oct 20, 2026
Primary completion
Oct 22, 2021→Dec 31, 2019
moved 2 times, Oct 20, 2026 – Oct 26, 2026
Study completion
Oct 22, 2021→Sep 15, 2021 (actual)
Oct 20, 2026
Publications
Results publication added: 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 ↗
Oct 26, 2026
Show all 2 updates
  1. Oct 26, 2026
    Publications Results publication added: 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 ↗
    Primary completion Sep 15, 2021→Dec 31, 2019
  2. Oct 20, 2026
    Status unknown→Completed
    Start date Oct 23, 2017→Oct 25, 2017
    Primary completion Oct 22, 2021→Sep 15, 2021 (now actual)
    Study completion Oct 22, 2021→Sep 15, 2021 (now actual)
    + 5 other changes: verification date, description, contact details, site details and index terms

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 ↗

10

Registry details

Key details

Study ID
NCT03350139
Responsible party
Sponsor
First posted
Nov 22, 2017
Start date
Oct 25, 2017
Primary completion
Dec 31, 2019
Completion
Sep 15, 2021
Last update
Oct 26, 2026

Study contacts

Jean-Olivier ARNAUD, General Director
study director · Assistance Publique Hôpitaux de Marseille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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Discussion

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