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

Sponsor
Exoneural Network AB
Study ID
NCT05901259
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EXOPULSE Mollii Suit and EXOPULSE Suit — DEVICE
    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).

Study Details

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.

Key Dates

First listed
Jun 13, 2023
Start date
Feb 18, 2026
Status verified
Feb 2026
Primary completion
Aug 1, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
200 participants (estimated)

Primary Outcome Measure

Berg's Balance Scale [ Time Frame: To be assessed at baseline, after 60 minutes stimulation (T1), and after 2 weeks of home use (T2). ]

Central Contacts

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