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

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

Recruiting
18-99 years
All
Phase N/A

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Overview

  • 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.

Eligibility

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

Study details
    Stroke
    Multiple Sclerosis

NCT07333222

Somogy Megyei Kaposi Mór Teaching Hospital

1 February 2026

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