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EXOPULSE Mollii Suit, Motor Function & Multiple Sclerosis

CompletedNA

Sponsor: Institut De La Colonne Vertebrale Et Des Neurosciences

Conditions: Multiple Sclerosis

Interventions: EXOPULSE MOLLII SUIT (active), EXOPULSE MOLLII SUIT (sham)

Countries: France

Spasticity is a frequent and debilitating symptom in patients with multiple sclerosis (MS). It can alter the patients' balance, mobility, as well as their quality of life. The available therapeutic strategies for treating spasticity and related symptoms are usually faced with limited efficacy and numerous side effects. For these reasons, non invasive stimulation techniques, namely transcutaneous stimulation by means of EXOPULSE Mollii suit, might be of help in this context.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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).
* 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.
* Having a BBS score ≤46 associated in the literature with a risk of fall

Exclusion Criteria:

* Being included in another research protocol during the study period.
* Inability to undergo medical monitoring 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.

Locations (1)

Créteil, VAL DE MARNE, France