EXOPULSE Mollii Suit, Motor Function & Multiple Sclerosis

NCT06702137 | Completed

• 1 other identifier: 2022-A00231-42
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Spasticity is a frequent and debilitating symptom in patients with multiple sclerosis (MS). It can alter the patients' balance, mobility, as well as their quality of life. The available therapeutic strategies for treating spasticity and related symptoms are usually faced with limited efficacy and numerous side effects. For these reasons, non invasive stimulation techniques, namely transcutaneous stimulation by means of EXOPULSE Mollii suit, might be of help in this context.

Conditions

Multiple Sclerosis

Keywords

Spasticity; Motor Functions; Quality of life

Outcome Measures

Primary Outcomes (1)

• Improvement in balance using the BBS (Berg Balance Scale) )

  Balance will be assessed using the 14-item Berg Balance Scale (BBS) which has good psychometric properties in PwMS (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 the risk of falls across the literature.

  BBS will be evaluated at Day 1 (before & after the intervention, phase 1) and at Day 15 (before & after the intervention, phase 1)

Secondary Outcomes (11)

• Assessment of the cumulative effects of EXOPULSE Mollii suit on balance using the BBS (Berg Balance Scale) after 4 weeks of using Exopulse Molii Suit

  BBS evaluation will occur at Day 30 (before phase 2) and at Day 60 (at the end of phase 2)

• Assessment of the spasticity using the MAS (Modified Ashworth Scale)

  Spasticity according to MAS will be assessed through study completion at Day 1 (before and after the intervention, phase 1), at Day 15 (before and after the intervention, phase 1), at Day 30 (before phase 2) and at Day 60 (at the end of phase 2)

• Assessment of the spasticity using the VAS spasticity (Visual Analogue Scale)

  VAS spasicity will be assessed through study completion at Day 1 (before and after the intervention, phase 1), at Day 15 (before and after the intervention, phase 1), at Day 30 (before phase 2) and at Day 60 (at the end of phase 2)

• Mobility will be assessed using the TUG (Time Up and Go)

  Mobility according to TUG will be assessed through study completion at Day 1 (before and after the intervention, phase 1), at Day 15 (before and after the intervention, phase 1), at Day 30 (before phase 2) and at Day 60 (at the end of phase 2)

• Mobility will be assessed using the FES-I (Falls Efficacy Scale-International scale)

  FES-I will be assessed at Day 30 (before phase 2) and at Day 60 (at the end of phase 2)

Study Arms (2)

Experimental Condition

ACTIVE COMPARATOR

Active sessions will last 1 hour each. The following parameters will be used for electric stimulation: low frequency (20 Hz), low current intensity (2 mA), with a small pulse width of 25-170 microseconds. These parameters were previously found to be safe in human studies. Based on the clinical exam of each patient, the spastic muscles will be targeted. EXOPULSE Mollii Suit is used for the activation of weak muscles or relaxation of spastic muscles mediated by a physiological reflex mechanism referred to as reciprocal inhibition. By sending an electrical signal to an antagonistic muscle, the spastic muscle will subsequently relax.

Device: EXOPULSE MOLLII SUIT (active)

Control Condition

SHAM COMPARATOR

In the control condition, the patients will receive a sham stimulation, for which the control unit will be programmed to start stimulating for 1 minute then it will shut off. There is no risk related to the sham intervention since it consists of applying the same parameters used for the active session (low frequency: 20 Hz; current intensity: 2 mA; pulse width ranging from 25 to 170 µs) but for a shorter duration of time (1 minute instead of 1 hour).

Device: EXOPULSE MOLLII SUIT (sham)

Interventions

EXOPULSE MOLLII SUIT (active) DEVICE

This study aims to evaluate the effects of the EXOPULSE Mollii suit, a non-invasive assistive device that delivers transcutaneous electrostimulation. The suit includes a CE-labeled class IIa control unit and class I body garments. Equipped with 58 electrodes, the full-body suit stimulates various muscle groups to reduce spasticity by activating antagonistic muscles through reciprocal inhibition, rather than causing muscle contractions. Designed to relax spastic muscles, improve range of motion, prevent atrophy, enhance circulation, and provide pain relief, the device is easy to use, requiring only one hour of daily wear, with effects lasting over 24 hours. Current treatments for spasticity, such as botulinum toxin and oral medications, have limitations like side effects and minimal mobility improvement. The EXOPULSE Mollii suit offers an innovative alternative, with early studies indicating positive impacts on mobility and motor function.

Experimental Condition

EXOPULSE MOLLII SUIT (sham) DEVICE

In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off.

Control Condition

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 French speaker, able to understand verbal instructions, and affiliated to the national health insurance (sécurité sociale).
• 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 monitoring 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/m2.
• In case of the introduction of a medical device other than EXOPULSE Mollii suit during the study period
• Patients under juridical protection (" mesure de protection judiciare : tutelle, curatelle, sauvegarde de justice ")
• Prisoners.

Sponsors & Collaborators

• Institut De La Colonne Vertebrale Et Des Neurosciences: lead

Study Sites (1)

Clinical Neurophysiology Department, Henri Mondor Hospital

Créteil, VAL DE MARNE, 94000, France

Location

Related Publications (1)

• Ayache SS, Mattar JG, Creange A, Abdellaoui M, Zedet M, Lefaucheur JP, Megherbi H, Khaled H, Abi Lahoud GN, Chalah MA. The effect of the EXOPULSE Mollii suit on motor functions in patients with multiple sclerosis - a randomized sham-controlled crossover trial. Mult Scler J Exp Transl Clin. 2025 Jun 19;11(2):20552173251348304. doi: 10.1177/20552173251348304. eCollection 2025 Apr-Jun.

  PMID: 40547078 DERIVED

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

Study Officials

• Samar S AYACHE, MD, PhD

  Clinical Neurophysiology department, Henri Mondor Hospital, Creteil, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It is a randomized, controlled, double-blind, and cross-over study. Phase 1 is a randomized, controlled, double-blind, and cross-over study. In this phase, each participant will be randomly assigned to receive one session of active stimulation and one session of sham stimulation using the EXOPULSE Mollii suit (phase 1). The crossover design is appropriate for assessing symptomatic treatment of this chronic and relatively stable disease. Furthermore, the sessions will be separated by a wash-out interval of two weeks. Thus, a 2-week washout period should be enough to prevent a potential carry-over effect. At the end of phase 1 (two weeks after the second session of active or sham), an open-label phase (phase 2) will be proposed for all patients and will consist of 4 weeks of active stimulation (every other day stimulations for a total of 14 sessions). In total, each participant will be included in the study for 8 weeks (4 weeks for phase 1 and 4 weeks for phase 2).

Study Record Dates

• First Submitted: November 2, 2024
• First Posted: November 22, 2024
• Study Start: June 1, 2022
• Primary Completion: April 2, 2024
• Study Completion: May 14, 2024
• Last Updated: June 18, 2025

Record last verified: 2025-02

Locations

FR (1)