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EXOPULSE Mollii Suit, Motor Function & Stroke (EXOSTROKE)

EXOPULSE Mollii Suit, Motor Function & Stroke (EXOSTROKE)

Recruiting
18-75 years
All
Phase N/A

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Overview

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.

Eligibility

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • 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).
  • Being pregnant (confirmed by a blood beta-HCG test).
  • Having a change in their pharmacological therapy in the last three months.
  • Suffering from other somatic or neuropsychiatric diagnoses (e.g., arrhythmias, uncontrolled epilepsy, diseases causing osteoarticular and muscular pain).
  • 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 ".)

Study details
    Spasticity As Sequela of Stroke

NCT06702163

Institut De La Colonne Vertebrale Et Des Neurosciences

21 October 2025

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