EXOPULSE Mollii Suit, Motor Function & Multiple Sclerosis

Launched by INSTITUT DE LA COLONNE VERTEBRALE ET DES NEUROSCIENCES · Nov 20, 2024

Keywords

ClinConnect Summary

The EXOPULSE Mollii Suit trial is studying a new way to help people with multiple sclerosis (MS) manage a common and troublesome symptom called spasticity. Spasticity can cause muscle stiffness and spasms, which may affect balance and mobility, making daily activities more challenging. The trial is testing a special suit that uses non-invasive stimulation to see if it can improve movement and quality of life for those living with MS.

To participate in the trial, you must be between 18 and 75 years old, have been diagnosed with MS for at least one month, and be able to walk with or without support. You should also have experienced spasticity and be free of relapses for the last three months. Participants will be asked to wear the suit and may experience some benefits in their mobility and comfort. It’s important to know that this study is currently recruiting participants, and you should not be enrolled in any other research during this time. If you think you might be eligible and are interested in improving your spasticity symptoms, this trial could be a great opportunity!

Gender

ALL

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.