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

NCT05857280 | Recruiting DMC

• 1 other identifier: EXOSEP2
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• Balance using Berg Balance Scale (BBS)

  Balance will be assessed using the 14-item Berg Balance Scale (BBS) which has good psychometric properties in Patients with Multiple Sclerosis (concurrent validity, interrater reliability). The scale rates the balance using 56 points, with higher scores indicating better balance abilities. A score equal to or below 45 is commonly associated with risk of fall across the literature.

  To be assessed at baseline.

• Balance using Berg Balance Scale (BBS)

  Balance will be assessed using the 14-item Berg Balance Scale (BBS) which has good psychometric properties in Patients with Multiple Sclerosis (concurrent validity, interrater reliability). The scale rates the balance using 56 points, with higher scores indicating better balance abilities. A score equal to or below 45 is commonly associated with risk of fall across the literature.

  To be assessed at week 2.

• Balance using Berg Balance Scale (BBS)

  Balance will be assessed using the 14-item Berg Balance Scale (BBS) which has good psychometric properties in Patients with Multiple Sclerosis (concurrent validity, interrater reliability). The scale rates the balance using 56 points, with higher scores indicating better balance abilities. A score equal to or below 45 is commonly associated with risk of fall across the literature.

  To be assessed at week 4.

• Balance using Berg Balance Scale (BBS)

  Balance will be assessed using the 14-item Berg Balance Scale (BBS) which has good psychometric properties in Patients with Multiple Sclerosis (concurrent validity, interrater reliability). The scale rates the balance using 56 points, with higher scores indicating better balance abilities. A score equal to or below 45 is commonly associated with risk of fall across the literature.

  To be assessed at week 8.

Secondary Outcomes (13)

• Visual Analog Score for spasticity.

  This to be assessed at baseline, then at week 2, week 4 and week 8.

• Mobility.

  Two weeks after the second stimulation and 4 weeks later at the end of phase 2.

• Visual Analog Score for pain.

  This to be assessed at baseline, then at week 2, week 4 and week 8.

• Multiple Sclerosis International Quality of Life Questionnaire.

  Two weeks after the second stimulation and 4 weeks later at the end of phase 2.

• Overall Clinical improvement.

  This to be assessed at baseline, then at week 2, and week 8.

Study Arms (2)

EXOPULSE Mollii Suit Stimulation Active

ACTIVE COMPARATOR

This will be the EXOPULSE Mollii Suit Active Stimulation. Stimulation will go on for 60 minutes while control unit is on for 60 minutes.

Device: EXOPULSE Mollii Suit Stimulation

EXOPULSE Mollii Suit Stimulation Sham

SHAM COMPARATOR

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.

Device: EXOPULSE Mollii Suit Stimulation

Interventions

EXOPULSE Mollii Suit Stimulation DEVICE

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.

EXOPULSE Mollii Suit Stimulation Active; EXOPULSE Mollii Suit Stimulation Sham

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Being included in another research protocol during the study period.
• Inability to undergo medical monitor for the study purposes due to geographical or social reasons.
• Having a cardiac stimulator, a ventriculoperitoneal shunt, an intrathecal baclofen pump or other contraindications to using EXOPULSE Mollii suit.
• Being pregnant.
• Having a change in their pharmacological therapy in the last three months.
• Suffering from other somatic or neuropsychiatric diagnoses (e.g., arrhythmias, uncontrolled epilepsy, diseases causing osteoarticular and muscular pain).
• Having a body mass index above 35 kg/m\^2.
• In case of the introduction of a medical device other than EXOPULSE Mollii suit during the study period.
• Patients under juridical protection.
• Prisoners.

Sponsors & Collaborators

• Sheikh Shakhbout Medical City: lead

Study Sites (1)

SSMC

Abu Dhabi, United Arab Emirates

RECRUITING

Related Publications (46)

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MeSH Terms

Conditions

Multiple Sclerosis; Muscle Spasticity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Naji J Riachi, MD

CONTACT

+971 2 314 4444; nriachi@ssmc.ae

Hasan M Jaber, Bsc

CONTACT

+971 2 314 4444; hasjaber@ssmc.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: May 12, 2023
• Study Start: March 21, 2023
• Primary Completion: December 31, 2024
• Study Completion: April 15, 2025
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)