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

NCT06384729 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-06-17

No results posted yet for this study

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

Interventions

DEVICE

EXOPULSE Mollii Ⓡ

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.

Sponsors & Collaborators

  • Universidad Europea de Madrid

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2024-05-01
Completion
2024-09-01

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06384729 on ClinicalTrials.gov