EXOPULSE Mollii Suit, Spasticity, Muscular Oxygenation & Multiple Sclerosis (ENNOX 2)
Sclerosis, Multiple, MS (Multiple Sclerosis), Spastic
About this trial
This is an interventional supportive care trial for Sclerosis, Multiple
Eligibility Criteria
Inclusion Criteria: 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. Having spasticity with a score of at least 1+ on the MAS. Female patients of child-bearing potential must agree to use adequate birth control measures Voluntarily given, fully informed written and signed consent obtained before any study related procedures are conducted Exclusion Criteria: 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. Prisoners.
Sites / Locations
- SSMCRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
EXOPULSE Mollii Suit Stimulation Active.
EXOPULSE Mollii Suit Stimulation Sham.
This will be the EXOPULSE Mollii Suit Active Stimulation. Stimulation will go on for 60 minutes while control unit is on for 60 minutes.
This will be the EXOPULSE Mollii Suit Sham Stimulation. Stimulation will go on for 1 minute then it turns off while the control unit will remain on for total of 60 minutes.