StrokeNCT07333222
Functional and Quality of Life Effects of the Mollii Neuromodulatory Suit in Patients With Stroke and Multiple Sclerosis
A study testing the Mollii garment with active stimulation in people with Stroke and Multiple Sclerosis, run by Somogy Megyei Kaposi Mór Teaching Hospital at 1 site in Hungary.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Stroke, Multiple Sclerosis
- What is being tested?
- the Mollii garment with active stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteHungary
- Study dates
- 12 Jan 2026to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary1 site, 1 recruiting
- Recruiting
Somogy County Kaposi Mór Teaching Hospital
Kaposvár, Somogy County, 7400
Barbara Kopácsi, +36308340545, kbarbi0108@gmail.com
József Dr. habil Tollár, +36306994497, tollarjozsef86@gmail.com
About this study
Official title: Prospective, Placebo-controlled Study on the Functional and Quality of Life Effects of the Mollii Neuromodulatory Suit in Patients With Stroke and Multiple Sclerosis
- 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.
- Conditions
- Stroke, Multiple Sclerosis
- Being tested
- the Mollii garment with active stimulation, Mollii neuromodulation garment, but the stimulation program is not activated (placebo)
- Keywords
- Stroke, Multiple Sclerosis, Mollii neuromodulation suit, Rehabilitation, Balance
- Medical subject headings
- Stroke, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the Mollii garment with active stimulationOther
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.
Mollii neuromodulation garment, but the stimulation program is not activated (placebo)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Mollii Group | Experimental | Receaving treatment with the stimulation program. Receives: Other: the Mollii garment with active stimulation |
| Control Group | Placebo comparator | Receaving treatment without the stimulation program. Receives: Other: Mollii neuromodulation garment, but the stimulation program is not activated (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Independence Measure (FIM)
Functional autonomy, scaling 18-126 points. The lower the score, the less self-sufficient the patient is.
Measured: 4 weeks
Barthel Index (BI)
Everyday activities, scaling 0-100 points. The higher the score, the better the self-sufficiency.
Measured: 4 weeks
Secondary outcomes (9)
Stroke Impact Scale (SIS)
Physical and psychological functions after stroke scaling 0-100 points, higher score means better post-stroke functions.
Measured: 4 weeks
Multiple Sclerosis Impact Scale (MSIS-29)
Physical and psychological effects in MS, scaling 0-100 points, where higher scores mean greater disease impact.
Measured: 4 weeks
Berg Balance Scale (BBS)
Measures balance, scaling 0-56 points, with lower scores suggesting good balance/indipandance.
Measured: 4 weeks
Tinetti
Balance and walking, scaling 0-28 points, with lower scores indicating higher fall risk.
Measured: 4 weeks
Timed Up and Go (TUG)
Measures functional mobility and fall risk, scaling 0-180 seconds. The less time, the lower the risk of falling.
Measured: 4 weeks
6 minute walk test (6MWT)
Functional exercise capacity
Measured: 4 weeks
10 meter walk test (10mWT)
Walking speed
Measured: 4 weeks
Posturographic examination
Postural instability
Measured: 4 weeks
3D motion analysis
Movement dynamics, gait
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start12 Jan 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Somogy Megyei Kaposi Mór Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tollár József, Somogy Megyei Kaposi Mór Teaching Hospital
- Investigators
- József Dr. habil Tollár, Principal investigator, Somogy County Kaposi Mór Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333222
- Sponsor's protocol ID
- IG/4390-0/2025
- Status last verified
- Jan 2026
- First submitted
- 19 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Placebo-controlled Study on the Functional and Quality of Life Effects of the Mollii Neuromodulatory Suit in Patients With Stroke and Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07333222
- Acronym / sponsor ID
- IG/4390-0/2025
- Conditions
- Stroke, Multiple Sclerosis
- Keywords
- Stroke, Multiple Sclerosis, Mollii neuromodulation suit, Rehabilitation, Balance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Somogy Megyei Kaposi Mór Teaching HospitalUniversity, hospital or other
- Study start
- 12 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mollii Group | Experimental | Other: the Mollii garment with active stimulationReceaving treatment with the stimulation program. |
| Control Group | Placebo comparator | Other: Mollii neuromodulation garment, but the stimulation program is not activated (placebo)Receaving treatment without the stimulation program. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (25 listed)
- multiple strokes in medical history
- systolic blood pressure less than 120 or higher than 160 mmHg
- orthostatic hypotension
- arotid artery stenosis
- severe heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the Mollii garment with active stimulationPatients 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. | Other | Mollii Group |
| Mollii neuromodulation garment, but the stimulation program is not activated (placebo)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. | Other | Control Group |
Primary outcome
Functional Independence Measure (FIM)
Time frame: 4 weeks
Functional autonomy, scaling 18-126 points. The lower the score, the less self-sufficient the patient is.
Barthel Index (BI)
Time frame: 4 weeks
Everyday activities, scaling 0-100 points. The higher the score, the better the self-sufficiency.
9 secondary outcomes
Stroke Impact Scale (SIS)
Time frame: 4 weeks
Multiple Sclerosis Impact Scale (MSIS-29)
Time frame: 4 weeks
Berg Balance Scale (BBS)
Time frame: 4 weeks
Tinetti
Time frame: 4 weeks
Timed Up and Go (TUG)
Time frame: 4 weeks
6 minute walk test (6MWT)
Time frame: 4 weeks
10 meter walk test (10mWT)
Time frame: 4 weeks
Posturographic examination
Time frame: 4 weeks
3D motion analysis
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
József Dr. habil Tollár principal investigator
Somogy County Kaposi Mór Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the Mollii garment with active stimulation in people with Stroke and Multiple Sclerosis, run by Somogy Megyei Kaposi Mór Teaching Hospital at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbara Kopácsi (+36308340545, kbarbi0108@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Independence Measure (FIM) (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.