Status:
COMPLETED
Regional Non-comparative Prospective Study of the Impact of Gamma Knife Radiosurgery on Tremor in Multiple Sclerosis
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-70 years
Phase:
NA
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 comm...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2023
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03339908
Start Date
October 23 2017
End Date
April 4 2023
Last Update
April 6 2023
Active Locations (1)
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1
Assistance Publique Hôpitaux de Marseille
Marseille, France, 13354