CompletedNot Applicable

Exopulse Mollii Suit, Spasticity & Tissue Oxygenation

France28 participantsStarted 2022-03-01

Plain-language 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 and induce important changes in the muscular microcirculation, leading to oxidative changes within the muscular tissue. Such changes reflect altered aerobic metabolism and impaired mitochondrial function. 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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. * 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 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 (" mesure de protection judiciare : tutelle, curatelle, sauvegarde de justice ") * Prisoners.

What they're measuring

Changes in oxyhemoglobin level at baseline and at week 2.

Timeframe: This be assessed at baseline, then at week 2.

Changes in deoxyhemoglobin level at baseline and at week 2.

Timeframe: This be assessed at baseline, then at week 2.

Changes in tissue oxygenation index at baseline and at week 2.

Timeframe: This be assessed at baseline, then at week 2.

Change in total hemoglobin level at baseline and at week 2.

Timeframe: This be assessed at baseline and at week 2.

Trial details

NCT IDNCT05362006

SponsorInstitut De La Colonne Vertebrale Et Des Neurosciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-18

View on ClinicalTrials.gov More Multiple Sclerosis trials

Plain-language summary

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Changes in oxyhemoglobin level at baseline and at week 2.

Timeframe: This be assessed at baseline, then at week 2.

Changes in deoxyhemoglobin level at baseline and at week 2.

Timeframe: This be assessed at baseline, then at week 2.

Changes in tissue oxygenation index at baseline and at week 2.

Timeframe: This be assessed at baseline, then at week 2.

Change in total hemoglobin level at baseline and at week 2.

Timeframe: This be assessed at baseline and at week 2.