EXOPULSE Mollii Suit, Motor Function & Multiple Sclerosis

NCT ID: NCT06702137

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2024-05-14

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.

Detailed Description

The investigators 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. A 2-week washout period should be enough to prevent a potential carry over effect. Two weeks after the end of this phase (phase 1), a second phase of this trial, an open label phase, will be proposed for all patients to understand the effects of EXOPULSE Mollii suit employed over four weeks (a session every other day for a total of 14 sessions) on MS related symptoms.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Experimental Condition

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.

Group Type: ACTIVE_COMPARATOR

EXOPULSE MOLLII SUIT (active)

Intervention Type: 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.

Control Condition

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).

Group Type: SHAM_COMPARATOR

EXOPULSE MOLLII SUIT (sham)

Intervention Type: DEVICE

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

Interventions

EXOPULSE MOLLII SUIT (active)

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.

Intervention Type: DEVICE

EXOPULSE MOLLII SUIT (sham)

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut De La Colonne Vertebrale Et Des Neurosciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samar S AYACHE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Neurophysiology department, Henri Mondor Hospital, Creteil, France

Locations

Clinical Neurophysiology Department, Henri Mondor Hospital

Créteil, VAL DE MARNE, France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 40547078 (View on PubMed)

Other Identifiers

2022-A00231-42

Identifier Type: -

Identifier Source: org_study_id