NCT03339908

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Thalamotomy by gamma Knife radiosurgery	The surgical procedure consists of a very partial radiation of the brain with stereotaxic precision

Timeline

• Start date: 2017-10-23
• Primary completion: 2021-01-20
• Completion: 2023-04-04
• First posted: 2017-11-13
• Last updated: 2023-04-06

Locations

1 site across 1 country: France