NCT07333222

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Somogy Megyei Kaposi Mór Teaching Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke
• Multiple Sclerosis

Interventions

Type	Name	Description
OTHER	the Mollii garment with active stimulation	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.
OTHER	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.

Timeline

• Start date: 2026-01-12
• Primary completion: 2026-12-31
• Completion: 2028-08-01
• First posted: 2026-01-12
• Last updated: 2026-01-12

Locations

1 site across 1 country: Hungary