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NCT05857280

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

Recruiting now NA Last updated 17 April 2024
What this trial tests

NA trial testing EXOPULSE Mollii Suit Stimulation in Sclerosis, Multiple in 36 participants. Currently enrolling.

Timeline
21 March 2023
Primary endpoint
31 December 2024
15 April 2025

Quick facts

Lead sponsorSheikh Shakhbout Medical City
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposesupportive care
Enrollment36
Start date21 March 2023
Primary completion31 December 2024
Estimated completion15 April 2025
Sites1 location across United Arab Emirates

Drugs / interventions tested

Conditions studied

Sponsor

Sheikh Shakhbout Medical City

Who can join

Adults 18 to 75, any sex, with Sclerosis, Multiple or MS (Multiple Sclerosis). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of EXOPULSE Mollii Suit Stimulation

Trials testing the same drug.

Other recruiting trials for Sclerosis, Multiple

Currently open trials in the same condition.

Other Sheikh Shakhbout Medical City trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing