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

Introduction:

Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system with unknown etiology. Common symptoms include fatigue, visual disturbances, balance and coordination problems, sensory disturbances, spasticity, cognitive and emotional disorders, speech impairments, bladder and bowel issues, and sexual dysfunction. MS affects approximately 2.2 million people worldwide. Gait abnormalities are a distinctive feature of MS and a significant cause of disability and reduced health-related quality of life. Individuals with MS typically exhibit slower walking speeds, lower cadence, and increased variability between strides, attributed to demyelination resulting in reduced conductivity in the somatosensory nervous system, decreased muscle strength, vestibular dysfunction, and severe fatigue.

The EXOPULSE Mollii Ⓡ method is an innovative approach to non-invasive, self-administered electrical stimulation using multiple electrodes incorporated into a full-body suit. Comprising comfortable, breathable, and washable synthetic material, the Mollii Ⓡ suit primarily aims to alleviate disabling spasticity and enhance motor function. The method operates on the concept of reciprocal inhibition induced by stimulating the antagonist of a spastic muscle at low frequencies and intensities, thus considered to reduce spasticity. Moreover, the EXOPULSE Mollii Ⓡ suit has demonstrated benefits in children with cerebral palsy, spasticity, and chronic stroke patients. Therefore, this study aims to evaluate the effects of a 60-minute session with the EXOPULSE Mollii Ⓡ suit on patients with multiple sclerosis.

Methodology:

A randomized, double-blind clinical trial will be conducted, with two investigators performing the intervention and a third responsible for programming the suits and attaching the belt. Patients will be recruited from the Fivan Foundation, where the intervention will take place. Recruitment and patient selection will be conducted through therapists at the center, informed in advance about the project's content. The suits, provided by the Fivan Foundation and Ottobock, consist of comfortable, breathable, and washable synthetic pants and jackets. Patients meeting the following inclusion criteria will be selected:

• Diagnosed with multiple sclerosis by their physician
• Aged 18 or above.
• Able to understand verbal commands.
• Having a Functional Ambulation Category (FAC) score between 2 and 4.

Exclusion criteria include:

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

Patients will be randomly divided into two groups using a coin toss method. An initial individual assessment session will be conducted, including randomization, providing each patient with an assessment sheet, and obtaining informed consent. The control group will wear the Exopulse Mollii Ⓡ suit with parameters set to 0, while the second group will wear the same suit with parameters adjusted to each individual assessment. Both groups will undergo 60-minute sessions, three times a week for three weeks, to assess potential beneficial effects of this device for MS patients. At three weeks, a crossover will occur, with the group initially having parameters set to 0 now receiving treatment for another 3 weeks, while the other group will have the treatment discontinued to assess maintenance of effects. Initial, 3-week, and 6-week assessments will be conducted for both groups using previously validated scales detailed in the following section. This intervention will be added to the patient's usual treatment without interfering with it. Sample size was determined using the GRANMO© program, with 11 subjects per group, considering an alpha risk of 0.05, a beta risk below 0.2 in a bilateral contrast, and an estimation based on a common standard deviation of 4.89, taking into account a 5% follow-up loss rate.