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The Exopulse Mollii Suit Study - a Database for Routine Follow-up of Clinical Outcomes

Study Purpose

The objective is to explore the potential short and long-term impact of the Exopulse Mollii Suit on subjects with CP, MS, stroke, SCI or other neurological 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 improvement on the Berg/Pediatric Balance Scale (BBS) as a measurement of balance and risk of falls.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	2 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Diagnosed with CP, MS, stroke, spinal cord injury or other neurologic disorder that may cause such type of symptoms.

- Diagnosed >6 months prior to inclusion in case of MS, stroke, or SCI.

- 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.

- 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05901259
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Exoneural Network AB
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Mimi Westerlund, Phd
Principal Investigator Affiliation	Exoneural Network AB
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries	Sweden
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cerebral Palsy, Multiple Sclerosis, Stroke, Spinal Cord Injuries, Neurologic Disorder

Additional Details

The registry is designed to demonstrate the impact of Exopulse Mollii Suit on improvement and 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 cannot 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Exoneural Network Ab, Bergshamra, Stockholm, Sweden

Status

Address

Exoneural Network Ab

Bergshamra, Stockholm, 170 73

Site Contact

[email protected]

+46-(0)707 62 99 41

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