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EXOPULSE Mollii Suit, Motor Function & Multiple Sclerosis (EXOSEP 2)
Sponsor: Sheikh Shakhbout Medical City
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.
Official title: The Effects of EXOPULSE Mollii Suit on Motor Functions in Patients With Multiple Sclerosis (EXOSEP 2)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2023-03-21
Completion Date
2025-04-15
Last Updated
2024-04-17
Healthy Volunteers
No
Interventions
EXOPULSE 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