Status:
COMPLETED
Exopulse Mollii Suit, Spasticity & Tissue Oxygenation
Lead Sponsor:
Institut De La Colonne Vertebrale Et Des Neurosciences
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Spasticity is a frequent and debilitating symptom in patients with multiple sclerosis (MS). Sustained contractile activity, such as that observed in spastic muscles, could reduce the capillary density...
Eligibility Criteria
Inclusion
- Definite MS diagnosis according to the 2017 McDonald criteria since at least one month.
- Age between 18 and 75 years.
- Ability to walk freely or with the need of support (expanded disability status scale score (EDSS) \< 7.5).
- Being free of relapses in the last three months.
- Being French speaker, able to understand verbal instructions, and affiliated to the national health insurance (sécurité sociale).
- Having spasticity with a score of at least 1+ on the MAS.
Exclusion
- Being included in another research protocol during the study period.
- Inability to undergo medical monitor for the study purposes due to geographical or social reasons.
- Having a cardiac stimulator, a ventriculoperitoneal shunt, an intrathecal baclofen pump or other contraindications to using Exopulse Mollii suit.
- Being pregnant
- Having a change in their pharmacological therapy in the last three months.
- Suffering from other somatic or neuropsychiatric diagnoses (e.g., arrhythmias, uncontrolled epilepsy, diseases causing osteoarticular and muscular pain).
- Having a body mass index above 35 Kg/m2
- In case of the introduction of a medical device other than Exopulse Mollii suit during the study period.
- Patients under juridical protection (" mesure de protection judiciare : tutelle, curatelle, sauvegarde de justice ")
- Prisoners.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2023
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT05362006
Start Date
March 1 2022
End Date
May 30 2023
Last Update
June 26 2025
Active Locations (1)
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1
Hopital Henri Mondor
Créteil, France, 94010