Using the EXOPULSE Mollii Suit to Improve Motor Functions in Multiple Sclerosis Patients
The Effects of EXOPULSE Mollii Suit on Motor Functions in Patients With Multiple Sclerosis (EXOSEP 2)
This study is testing if wearing the EXOPULSE Mollii suit can help people with multiple sclerosis improve their movement and feel better overall.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sheikh Shakhbout Medical City Academic / other |
| Locations | 1 site (Abu Dhabi) |
| Trial ID | NCT05857280 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of the EXOPULSE Mollii suit in improving motor functions and reducing symptoms related to multiple sclerosis (MS) and spasticity. Participants will undergo a randomized crossover design where they will receive either active or sham stimulation sessions, followed by evaluations of balance, mobility, muscle tone, pain, fatigue, and quality of life. After the initial phase, participants will enter an open-label phase where they will receive active stimulation at home for four weeks to assess long-term effects. The study is designed to be double-blind to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a confirmed diagnosis of multiple sclerosis and spasticity who can walk independently or with support.
Not a fit: Patients with severe disabilities (EDSS score ≥ 7), other serious medical conditions, or those currently participating in other research protocols may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance mobility and quality of life for patients with multiple sclerosis and spasticity.
How similar studies have performed: While the use of electrical stimulation for MS symptoms is explored in other studies, the specific application of the EXOPULSE Mollii suit represents a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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 able to understand verbal instructions. * 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 monitor 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/m\^2. * In case of the introduction of a medical device other than EXOPULSE Mollii suit during the study period. * Patients under juridical protection. * Prisoners.
Where this trial is running
Abu Dhabi
- Ssmc — Abu Dhabi, United Arab Emirates (Recruiting)
Study contacts
- Study coordinator: Naji J Riachi, MD
- Email: nriachi@ssmc.ae
- Phone: +971 2 314 4444
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.