RecruitingNCT05901259

The EXOPULSE Study - a Database for Routine Follow-up of Clinical Outcomes

Sponsor

Exoneural Network AB

Enrollment

200 participants

Start Date

Feb 18, 2026

Study Type

OBSERVATIONAL

Conditions

Stroke Neurologic Disorder Multiple Sclerosis Fibromyalgia Cerebral Palsy

Summary

The objective is to explore the potential short and long-term impact of the EXOPULSE Mollii Suit and EXOPULSE Suit on subjects with CP, MS, stroke, fibromyalgia or other neurologic disorders which may cause such types of symptoms, and to identify high responders among the sub-categories of the diagnoses. The primary endpoint will be improvements in the Berg/Pediatric Balance Scale (BBS/PBS) as a measurement of balance and risk of falls.

Eligibility

Min Age: 2 Years

Plain Language Summary

Simplified for easier understanding

This study is building a patient registry to track long-term outcomes in people with neurological conditions — such as cerebral palsy, multiple sclerosis, stroke, or fibromyalgia — who use the EXOPULSE Mollii Suit, a garment that delivers mild electrical stimulation to help manage muscle stiffness and spasticity. **You may be eligible if...** - You are at least 2 years old - You have been diagnosed with cerebral palsy, MS, stroke, fibromyalgia, or another neurological condition causing similar symptoms - Your diagnosis has been established for at least 6 months (for MS or stroke) or at least 1 month (for fibromyalgia) - You understand the study and can provide written consent **You may NOT be eligible if...** - You have a condition that makes using the suit unsafe (per manufacturer guidelines) - You started a new medication affecting muscle or nerve activity during the study - You used botulinum toxin (Botox) within the past 3 months - You are under 100 cm or 13 kg, or over 205 cm or 115 kg Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEXOPULSE Mollii Suit and EXOPULSE Suit

The registry is designed to demonstrate the impact of EXOPULSE Mollii Suit or EXOPULSE Suit on muscle relaxation, muscle activation, local blood circulation and/or chronic pain relief. The subjects included use the suit for 60 minutes every other day, unless other is specified by the Investigator, in their home environment for up to a maximum of 2 consecutive weeks. Qualitative and quantitative measures will be collected at baseline (T0), after 60 minutes stimulation (T1), after 2 weeks of home use (T2) and during two additional phone calls 1-3 days after the first stimulation session (T1,5) as well as 4 weeks after the first stimulation session (T3).