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

Exoneural Network

Status: Enrolling

Conditions: Fibromyalgia; Stroke; Multiple Sclerosis; Cerebral Palsy; Neurologic Disorder

Treatments: Device: EXOPULSE Mollii Suit and EXOPULSE Suit

Study type: Observational

Funder types: Industry

Identifiers

NCT05901259

CIV-22-08-040366

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with CP, MS, stroke, fibromyalgia or other neurologic disorder that may cause such type of symptoms.
• Diagnosed >6 months prior to inclusion in case of MS or stroke as well as >1 month prior to inclusion in the case of fibromyalgia.
• Give written informed consent
• Cognitively able to understand and follow verbal and/or written instructions
• A minimum age of 2 years

Exclusion criteria

• Any of the contraindications listed in the instructions for use of the EXOPULSE Mollii Suit or EXOPULSE Suit
• Being introduced to any new medication affecting the neuromuscular activity during the study period
• Using botulinum toxin <3 month before or during the study period
• Subjects <100 cm and <13 kg
• Subjects >205 cm and >115 kg