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Trial record 86 of 158 for:    genetics AND Parkinson's disease

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. (GARP)

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ClinicalTrials.gov Identifier: NCT03350139
Recruitment Status : Recruiting
First Posted : November 22, 2017
Last Update Posted : November 22, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief 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.


Condition or disease Intervention/treatment
Severe Disabling Tremor Device: gamma knife radiosurgery

Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Actual Study Start Date : October 23, 2017
Estimated Primary Completion Date : October 22, 2021
Estimated Study Completion Date : October 22, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor

Group/Cohort Intervention/treatment
Patients treated with gamma knife radiosurgery
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




Primary Outcome Measures :
  1. Clinical evaluation of tremor reduction in relation to clinical co-morbidity [ Time Frame: 12 months ]
    Clinical response increases with decrease in clinical co-morbidity



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03350139


Contacts
Contact: Jean REGIS, PU-PH 491387058 ext +33 jregis@ap-hm.fr

Locations
France
Assistance Publique Hôpitaux de Marseille Recruiting
Marseille, France, 13354
Contact: Jean REGIS, PU-PH    491387056 ext +33    jregis@ap-hm.fr   
Principal Investigator: Jean REGIS, PU-PH         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: Jean-Olivier ARNAUD, General Director Assistance Publique Hôpitaux de Marseille

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03350139     History of Changes
Other Study ID Numbers: 2017-09
ID RCB ( Registry Identifier: 2017-A01249-44 )
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms