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

NCT03339908 | Completed

• 2 other identifiers: 2016-222016-A01071-50
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• Scale evaluation Tremor and Coordination Scale (TACS)

  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

  12 months

• Scale evaluation Tremor and Coordination Scale (TACS)

  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

  24 months

Study Arms (1)

patients with Multiple Sclerosis

EXPERIMENTAL

Patients will benefit from unilateral thalamotomy by Gamma Knife radiosurgery

Device: Thalamotomy by gamma Knife radiosurgery

Interventions

Thalamotomy by gamma Knife radiosurgery DEVICE

The surgical procedure consists of a very partial radiation of the brain with stereotaxic precision

patients with Multiple Sclerosis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jean-Marie REGIS, PU-PH

  Assistance Publique Hôpitaux de Marseille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 13, 2017
• Study Start: October 23, 2017
• Primary Completion: January 20, 2021
• Study Completion: April 4, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-04

Locations

FR (1)