NCT05901259

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Exoneural Network AB · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The observational study (also referred to as the 'registry') is designed to demonstrate the impact of EXOPULSE Mollii Suit and EXOPULSE Suit on relaxation of muscles, muscle activation, local blood circulation and chronic pain relief. The subjects will serve as their own control and the data will be collected before, during and after the treatment period. As the electrical stimulation from the suit usually is above the level of sensation, the study participant will not be blinded to the treatment. To prevent bias, multiple investigators will be collecting the data and only standardized and validated methods will be used. All investigators will be trained on the measurements prior to the registry start. Additionally, all investigators are trained and certified in the EXOPULSE method, and the generic stimulation settings are selected according to a standardized matrix based on the subjects' age and level of impairment. Re-assessments during scheduled visits are part of normal routine and use. The decision whether the subjects will be enrolled in the registry is separated from the subject's decision to use the device.

Conditions

• Cerebral Palsy
• Multiple Sclerosis
• Stroke
• Neurologic Disorder
• Fibromyalgia

Interventions

Type	Name	Description
DEVICE	EXOPULSE 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).

Timeline

• Start date: 2026-02-18
• Primary completion: 2027-08-01
• Completion: 2027-12-31
• First posted: 2023-06-13
• Last updated: 2026-02-27

Locations

1 site across 1 country: Sweden