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Regional Non-comparative Prospective Study of the Impact of Gamma Knife Radiosurgery on Tremor in Multiple Sclerosis (GK-SEP)

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ClinicalTrials.gov Identifier: NCT03339908
Recruitment Status : Unknown
Verified November 2017 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : November 13, 2017
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Device: Thalamotomy by gamma Knife radiosurgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Regional Non-comparative Prospective Study of the Impact of Gamma Knife Radiosurgery on Tremor in Multiple Sclerosis
Actual Study Start Date : October 25, 2017
Estimated Primary Completion Date : October 25, 2020
Estimated Study Completion Date : October 25, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: patients with Multiple Sclerosis
Patients will benefit from unilateral thalamotomy by Gamma Knife radiosurgery
Device: Thalamotomy by gamma Knife radiosurgery
The surgical procedure consists of a very partial radiation of the brain with stereotaxic precision




Primary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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.

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): NCT03339908


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

Locations
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France
Assistance Publique Hôpitaux de Marseille Recruiting
Marseille, France, 13354
Contact: Jean-Marie REGIS, PU-PH    491387056    jean.regis@ap-hm.fr   
Principal Investigator: Jean-Marie REGIS, PU-PH         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Principal Investigator: Jean-Marie REGIS, PU-PH Assistance Publique Hôpitaux de Marseille
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03339908    
Other Study ID Numbers: 2016-22
2016-A01071-50 ( Registry Identifier: ID RCB )
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases