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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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).

• Being free of relapses in the last three months.

• Being able to understand verbal instructions.

• Having spasticity with a score of at least 1+ on the MAS.

• Having a BBS score ≤46 associated in the literature with a risk of fall.

Locations
Other Locations
United Arab Emirates
SSMC
RECRUITING
Abu Dhabi
Contact Information
Primary
Naji J Riachi, MD
nriachi@ssmc.ae
+971 2 314 4444
Backup
Hasan M Jaber, Bsc
hasjaber@ssmc.ae
+971 2 314 4444
Time Frame
Start Date: 2023-03-21
Estimated Completion Date: 2025-04-15
Participants
Target number of participants: 36
Treatments
Active_comparator: EXOPULSE Mollii Suit Stimulation Active
This will be the EXOPULSE Mollii Suit Active Stimulation. Stimulation will go on for 60 minutes while control unit is on for 60 minutes.
Sham_comparator: EXOPULSE Mollii Suit Stimulation Sham
This will be the EXOPULSE Mollii Suit Sham Stimulation. Stimulation will go on for 1 minute then it turns off while the control unit will remain on for total of 60 minutes.
Related Therapeutic Areas
Sponsors
Leads: Sheikh Shakhbout Medical City

This content was sourced from clinicaltrials.gov