Functional and Quality of Life Effects of the Mollii Neuromodulatory Suit in Patients With Stroke and 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
1 other identifier
interventional
40
1 country
1
Brief Summary
- Objective assessment of clinical symptoms resulting from stroke, as well as changes in mobility and quality of life, and determination of changes resulting from therapies
- Objective assessment of the quality of life, functionality, and clinical symptoms of patients with multiple sclerosis (MS) and determination of changes resulting from therapies
- Comparison of measured data from the two main neurological patient groups (stroke, multiple sclerosis) and follow-up of changes in relation to themselves and each other.
- Mapping the role of the placebo effect in neuromodulation devices by comparing subjective and objective outcomes.
- Analyzing the expectations and experiences of patients receiving placebo treatment using quality of life questionnaires.
- Analyzing the effects of the Mollii suit among subgroups of MS and stroke patients.
- Assessing the safety, possible side effects, and tolerability of the Mollii suit.
- Mapping changes in gait pattern due to the effects of therapy using 3D motion analysis.
- Examining the maintenance effects of neuromodulation during a 1-month follow-up.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable stroke
Started Jan 2026
Typical duration for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2025
CompletedFirst Posted
Study publicly available on registry
January 12, 2026
CompletedStudy Start
First participant enrolled
January 12, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
January 12, 2026
January 1, 2026
12 months
December 19, 2025
January 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Functional Independence Measure (FIM)
Functional autonomy, scaling 18-126 points. The lower the score, the less self-sufficient the patient is.
4 weeks
Barthel Index (BI)
Everyday activities, scaling 0-100 points. The higher the score, the better the self-sufficiency.
4 weeks
Secondary Outcomes (9)
Stroke Impact Scale (SIS)
4 weeks
Multiple Sclerosis Impact Scale (MSIS-29)
4 weeks
Berg Balance Scale (BBS)
4 weeks
Tinetti
4 weeks
Timed Up and Go (TUG)
4 weeks
- +4 more secondary outcomes
Study Arms (2)
Mollii Group
EXPERIMENTALReceaving treatment with the stimulation program.
Control Group
PLACEBO COMPARATORReceaving treatment without the stimulation program.
Interventions
Patients in the Intervention group attend therapy three days a week for four weeks, with each treatment lasting 60 minutes. In this group patients are fitted with the Mollii garment according to the same protocol, but in their case, active stimulation of the prescribed neuromodulation program is initiated.
CG patients are fully equipped with the Mollii neuromodulation garment, but the stimulation program is not activated. The patient thus completes the therapy without the device's perceptible electrical stimulation, preserving the blinding effect of the placebo-controlled setup. The total treatment time, setup process, and therapeutic environment are the same as for the intervention group.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Somogy County Kaposi Mór Teaching Hospital
Kaposvár, Somogy County, 7400, Hungary
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
József Dr. habil Tollár
Somogy County Kaposi Mór Teaching Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Department
Study Record Dates
First Submitted
December 19, 2025
First Posted
January 12, 2026
Study Start
January 12, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
August 1, 2028
Last Updated
January 12, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share