Mollii neuromodulation suit to improve function and quality of life after stroke or multiple sclerosis
Prospective, Placebo-controlled Study on the Functional and Quality of Life Effects of the Mollii Neuromodulatory Suit in Patients With Stroke and Multiple Sclerosis
This trial will test whether wearing the Mollii neuromodulation suit can improve mobility, balance, gait, and quality of life for people with stroke or multiple sclerosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Somogy Megyei Kaposi Mór Teaching Hospital Academic / other |
| Locations | 1 site (Kaposvár, Somogy County) |
| Trial ID | NCT07333222 on ClinicalTrials.gov |
What this trial studies
Participants with either a first ischemic stroke or confirmed multiple sclerosis will wear the Mollii garment with active electrical stimulation or a visually identical garment with the stimulation turned off (placebo). Objective measures of mobility, gait, balance, and clinical symptoms will be collected alongside patient-reported quality of life questionnaires, and participants will be followed over time to track changes. The protocol compares outcomes between the stroke and MS groups and examines the relationship between subjective reports and objective measures to map any placebo effect. Safety, tolerability, and subgroup differences will also be recorded.
Who should consider this trial
Good fit: Ideal candidates are adults with a first ischemic stroke causing mobility/postural limitations or adults with confirmed multiple sclerosis who can walk at least 10 meters (with or without assistance) and meet the trial's blood pressure, neurological, and functional criteria.
Not a fit: Patients with multiple prior strokes, severe cardiac or systemic comorbidity, uncontrolled blood pressure, severe aphasia or sensory/orthopedic impairments, seizure disorder, or those unable to walk 10 meters are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the Mollii suit could reduce spasticity and improve walking, balance, and daily functioning for some patients, leading to better quality of life.
How similar studies have performed: Small pilot studies and case series of the Mollii suit have reported mixed but sometimes promising effects on spasticity and function, while large randomized trials remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * suffered a first ischemic stroke, diagnosed by a neurologist based on CT or MR imaging * neurological examination revealed mobility and postural limitations * confirmed multiple sclerosis diagnosed by a neurologist based on MRI imaging Exclusion Criteria: * multiple strokes in medical history * systolic blood pressure less than 120 or higher than 160 mmHg * orthostatic hypotension * arotid artery stenosis * severe heart disease * hemophilia * traumatic brain injury * seizure disorder * untreated diabetes * abnormal electroencephalography * abnormal blood panel * use of sedatives * irregular medication use * severe aphasia (Western Aphasia Battery ≤ 25) * severe visual or hearing impairment * severe sensory dysfunction * severe orthopedic problems * other neurological conditions affecting motor function * alcoholism * drug use * smoking after diagnosis of stroke * unable to walk at least 10 m with or without assistance in 6 minutes * BBS score ≤ 32 * BI score ≤ 70 * current participation in individual or group exercise program outside of standard physical therapy
Where this trial is running
Kaposvár, Somogy County
- Somogy County Kaposi Mór Teaching Hospital — Kaposvár, Somogy County, Hungary (Recruiting)
Study contacts
- Principal investigator: József Dr. habil Tollár — Somogy County Kaposi Mór Teaching Hospital
- Study coordinator: Barbara Kopácsi
- Email: kbarbi0108@gmail.com
- Phone: +36308340545
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.