Effectiveness of the EXOPULSE Mollii Ⓡ Suit in Patients With Multiple Sclerosis

NCT06384729 | Completed

• 1 other identifier: 123
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Abstract: Background: Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system with unknown etiology, causing a variety of symptoms including impaired balance, coordination, and walking difficulties. The Exopulse Mollii Ⓡ suit is an innovative approach for non-invasive, self-administered electrical stimulation designed to alleviate spasticity and improve motor function in various neurological conditions. Objective: To determine the effectiveness of the Exopulse Mollii Ⓡ suit in improving motor control in patients with MS. Methods: A randomized, double-blind clinical trial will be conducted, recruiting patients diagnosed with MS , aged 18 or above, with a Functional Ambulation Category (FAC) score between 2 and 4. Patients will be randomly assigned to two groups receiving either inactive or active Exopulse Mollii Ⓡ treatment for 60 minutes, three times a week, for three weeks. Outcome measures include pain, balance, gait speed, risk of falls, perception of walking difficulties, and quality of life assessed using validated scales. Statistical analysis will be performed using SPSS v.29.0.0.0. Results: Data on age, sex, weight, and MS-related factors will be collected at baseline. Primary outcomes include changes in pain, balance, and gait speed, while secondary outcomes encompass risk of falls, perception of walking difficulties, and quality of life. Analysis will compare mean differences between groups using appropriate statistical tests. Conclusion: This study aims to evaluate the efficacy of the Exopulse Mollii Ⓡ suit in enhancing motor function in MS patients. Findings may contribute to the development of novel therapeutic strategies for managing MS-related symptoms and improving patients' quality of life.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (3)

• referred pain

  Visual analogue scale. Range: 0 to 10 Interpretation: Higher scores indicate higher levels of pain or symptoms.

  3 weeks

• Balance

  Berg Balance Scale; Range: 0 to 56 Interpretation: Higher scores indicate better balance and motor function.

  3 weeks

• gait speed and distance

  6 minutes walking test; Interpretation: Interpretation: Greater distances indicate better functional capacity and endurance.

  3 weeks

Secondary Outcomes (3)

• fall risk

  3 weeks

• perception of walking difficulties

  3 weeks

• perceived quality of life

  3 weeks

Study Arms (2)

Exopulse on group

EXPERIMENTAL

An individual assessment will be conducted to determine the parameters of the suit, and they will wear the suit for 60 minutes three times a week for three weeks. An initial assessment will be conducted, followed by another assessment after the 3-week treatment period.

Device: EXOPULSE Mollii Ⓡ

Exopulse of group

PLACEBO COMPARATOR

The suit will be worn with the parameters set to 0 for 60 minutes, three times a week, for three weeks. An initial assessment will be conducted, followed by another assessment after the 3-week treatment period. The suit will be worn with the parameters set to 0 for 60 minutes, three times a week, for three weeks. An initial assessment will be conducted, followed by another assessment after the 3-week treatment period.

Device: EXOPULSE Mollii Ⓡ

Interventions

EXOPULSE Mollii Ⓡ DEVICE

The EXOPULSE Mollii method (EXONEURAL NETWORK AB, Danderyd, Sweden) is an innovative approach to non-invasive and self-administered electrical stimulation with multiple electrodes incorporated into a full-body suit. It consists of comfortable, breathable, and washable synthetic material pants and a jacket. It has been primarily designed to reduce disabling spasticity and improve motor function. The method refers to the concept of reciprocal inhibition induced by stimulating the antagonist of a spastic muscle, at low frequencies and intensities, which is considered to reduce spasticity.

Exopulse of group; Exopulse on group

Eligibility Criteria

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

You may qualify if:

• Diagnosis of Multiple Sclerosis as confirmed by a physician using McDonald's criteria.
• Age over 18 years.
• Ability to comprehend verbal commands.
• Scoring between 2 and 4 on the Functional Ambulation Category (FAC).

You may not qualify if:

• Pregnancy.
• Having an intrathecal baclofen pump.
• Having received botulinum toxin injections in the last 3 months.
• Wearing electronic or magnetic medical devices (pacemakers, shunts, etc.) that may be affected by magnets.
• BMI \> 35.

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Study Sites (1)

Cecilia Estrada Barranco

Villaviciosa de Odón, Madrid, 28670, Spain

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: A randomized, double-blind clinical trial is proposed, in which two researchers will conduct the intervention, and a third researcher will be responsible for programming the suits and attaching the belt to the suit. The data will be analyzed by a fourth researcher.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 25, 2024
• Study Start: April 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: September 1, 2024
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)