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NCT06702163Completed

EXOPULSE Mollii Suit, Motor Function & Stroke (EXOSTROKE)

The Effects of EXOPULSE Mollii Suit on Motor Functions in Patients With Stroke (EXOSTROKE)

Source: ClinicalTrials.gov · Last updated 27 Feb 2026

Brief summary (registry, in English)

Spasticity is a common and debilitating complication in neurological conditions such as multiple sclerosis, cerebral palsy, and stroke. Stroke, a leading cause of global disability and death, occurs when blood flow to the brain is disrupted, causing neuronal damage. Approximately 80% of strokes are ischemic, with 20% being hemorrhagic. Several factors, including age, sex, vascular conditions, and lifestyle choices, increase the risk of stroke. Spasticity affects 19-28% of stroke survivors in the short term and up to 46% in the long term, severely impacting mobility and quality of life. Management typically involves pharmacological and nonpharmacological interventions, though these often have limited effectiveness and side effects. In this context, non-invasive techniques like transcutaneous stimulation with the EXOPULSE Mollii suit may offer a valuable alternative for managing spasticity and its associated symptoms.

Status (registry)
Completed
Study type
Interventional
Enrollment
30 (actual)
First submitted
3 Nov 2024
Start date
20 Dec 2022
Primary completion date
2 Apr 2025
Lead sponsor
Institut De La Colonne Vertebrale Et Des Neurosciences
Diseases
Stroke
NCT number
NCT06702163

What you commit to

  • Study type: Interventional
  • Participants enrolled: 30
  • From 20 Dec 2022 to the primary completion date, 2 Apr 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Having a change in their pharmacological therapy in the last three months.

Other illness

  • Having contraindications for using EXOPULSE Mollii suit (having implanted electronic medical devices or equipment which can be disrupted by magnets or an electronic life support equipment or high-frequency operation equipment; e.g., cardiac stimulator, ventriculoperitoneal shunt, intrathecal baclofen pump).
  • Suffering from other somatic or neuropsychiatric diagnoses (e.g., arrhythmias, uncontrolled epilepsy, diseases causing osteoarticular and muscular pain).

Other

  • Being included in another research protocol during the study period.
  • Inability to undergo medical monitor for the study purposes due to geographical or social reasons.
  • Being pregnant (confirmed by a blood beta-HCG test).
  • Having a body mass index above 35 Kg/m2.
  • In case of introducing a medical device other than EXOPULSE Mollii suit during the study period.
  • Patients under juridical protection (" mesure de protection) judiciare : tutelle, curatelle, sauvegarde de justice ")
  • Patients deprived of freedom (" personnes privées de liberté ".)

Who the study is looking for

  • Age between 18 and 75 years.
  • Having a clinical diagnosis of stroke for at least three months.
  • Being able to walk freely or with the need of support (modified Rankin score
    • 4).
  • Being a French speaker, able to understand verbal instructions, and affiliated. with the national health insurance (sécurité social).
  • Having spasticity with a score of at least 1+ on the MAS.
  • Having a Berg Balance Scale score ≤46 associated across the literature with a risk of fall.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Clinical Neurophysiology department, Henri Mondor Hospital, Creteil, France
Coordinator of this site? Confirm its status
CréteilFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.