Functional and Quality of Life Effects of the Mollii Neuromodulatory Suit in Patients With Stroke and Multiple Sclerosis

Somogy Megyei Kaposi Mór Teaching Hospital

Status: Enrolling

Conditions: Stroke; Multiple Sclerosis

Treatments: Other: the Mollii garment with active stimulation; Other: Mollii neuromodulation garment, but the stimulation program is not activated (placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT07333222

IG/4390-0/2025

Details and patient eligibility

About

• 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Mollii Group

Experimental group

Description:

Receaving treatment with the stimulation program.

Treatment:

Other: the Mollii garment with active stimulation

Control Group

Placebo Comparator group

Description:

Receaving treatment without the stimulation program.

Treatment:

Other: Mollii neuromodulation garment, but the stimulation program is not activated (placebo)