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

NCT05857280 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-04-17

No results posted yet for this study

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.

Conditions

  • Sclerosis, Multiple
  • MS (Multiple Sclerosis)
  • Spasticity, Muscle
  • Spastic

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Sheikh Shakhbout Medical City

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-21
Primary Completion
2024-12-31
Completion
2025-04-15

Countries

  • United Arab Emirates

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05857280 on ClinicalTrials.gov