Improving muscle oxygenation in multiple sclerosis patients using the Exopulse Mollii Suit
The Effects of EXOPULSE Mollii Suit on Spasticity and Muscular Oxygenation in Patients With Multiple Sclerosis.
This study is testing if wearing the Exopulse Mollii Suit can help adults with multiple sclerosis feel better by improving their muscle oxygenation and reducing symptoms like spasticity, pain, and fatigue.
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 | NCT05912595 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effects of the Exopulse Mollii Suit on muscular oxygenation and various symptoms in adult patients with 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 their condition. The study includes a two-week washout period to minimize carryover effects and a subsequent open-label phase to assess longer-term impacts of the treatment. Key outcomes include improvements in spasticity, pain, fatigue, quality of life, walking ability, and fall risk.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a confirmed diagnosis of Multiple Sclerosis and spasticity.
Not a fit: Patients with contraindications to the Exopulse Mollii Suit 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 the quality of life and functional abilities of patients with Multiple Sclerosis and spasticity.
How similar studies have performed: While the specific use of the Exopulse Mollii Suit is novel, similar approaches in managing spasticity and muscular oxygenation in MS have shown promising results in other studies.
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) \< 7.5). * Being free of relapses in the last three months. * Having spasticity with a score of at least 1+ on the MAS. * Female patients of child-bearing potential must agree to use adequate birth control measures * Voluntarily given, fully informed written and signed consent obtained before any study related procedures are conducted 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/m2. * 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.