RecruitingNot ApplicableNCT05857280

EXOPULSE Mollii Suit, Motor Function & Multiple Sclerosis (EXOSEP 2)

The Effects of EXOPULSE Mollii Suit on Motor Functions in Patients With Multiple Sclerosis (EXOSEP 2)


Sponsor

Sheikh Shakhbout Medical City

Enrollment

36 participants

Start Date

Mar 21, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to demonstrate the improvement of motor functions related symptoms in patients with MS and spasticity using Exopulse Mollii suit stimulation in Multiple Sclerosis patients with spasticity. The main questions it aims to answer are: * to evaluate the short-term impact of EXOPULSE Mollii suit on balance in adult MS patients suffering from spasticity. * to assess the effects of EXOPULSE Mollii suit on mobility, upper and lower limbs muscle tone, pain, fatigue and quality of life. Participants will participate in: * One baseline visit for inclusion during which the patient will undergo the first session (active or sham) along with evaluations (before and after the session) * One visit after two weeks during which the patient will undergo the second session (active or sham) along with evaluations (before and after the session) * One visit after two weeks of the second stimulation condition; the patients will undergo a third evaluation and receive the EXOPULSE Mollii Suit for the four-week open label phase and will use the suit at home for an active stimulation session every other day for four weeks. * One visit at the end of the open label phase to perform the fourth and last evaluation and return the EXOPULSE Mollii suit. Researchers will compare both Active and Sham groups to demonstrate the improvement of motor functions related symptoms in patients with MS and spasticity using Exopulse Mollii suit.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a full-body electrostimulation suit called the EXOPULSE Mollii Suit — which delivers gentle electrical impulses through the skin to reduce muscle stiffness (spasticity) — can improve movement and balance in people with multiple sclerosis (MS). **You may be eligible if...** - You are between 18 and 75 years old - You have a confirmed diagnosis of multiple sclerosis (MS) for at least one month - You can walk, with or without support (EDSS score below 7) - You have muscle spasticity (stiffness) and a balance score indicating a risk of falls - You have not had a relapse in the past 3 months **You may NOT be eligible if...** - You have a cardiac pacemaker, intrathecal baclofen pump, or ventriculoperitoneal shunt - You are pregnant - Your MS medications were changed in the last 3 months - You have a BMI above 35 - You have uncontrolled epilepsy, arrhythmia, or other serious medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEXOPULSE Mollii Suit Stimulation

We designed a randomized crossover, sham-controlled, double-blind trial to demonstrate the improvement of motor functions and MS related symptoms following a single session of "active" versus "sham" EXOPULSE Mollii suit stimulation. in phase 1, the patient will receive two stimulations separated by a two-week washout period. The patients will be randomized to receive either active/sham or sham/active and both patients and investigators will be blinded to the order in which the stimulation will be given. A 2-week washout period should be enough to prevent a potential carry over effect. Two weeks after the end of phase 1, a second open label phase (phase 2) of this trial will be proposed to all patients where they will receive active stimulation every other day at home over four weeks (for a total of 14 sessions). This will help understand the long term effects of EXOPULSE Mollii suit stimulation on MS related symptoms.


Locations(1)

SSMC

Abu Dhabi, United Arab Emirates

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NCT05857280


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