Using the EXOPULSE Mollii Suit to improve motor function in stroke patients with spasticity

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

This study is testing if wearing the EXOPULSE Mollii Suit can help stroke survivors with spasticity improve their movement and motor function.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 34 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Institut De La Colonne Vertebrale Et Des Neurosciences (other)
• Locations: 1 site (Creteil, Val de Marne)
• Trial ID: NCT06702163 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of the EXOPULSE Mollii Suit, a non-invasive device that uses transcutaneous stimulation, in managing spasticity in stroke survivors. Participants aged 18 to 75 with a clinical diagnosis of stroke and spasticity will be enrolled to assess improvements in motor function. The study will compare the active use of the suit against a sham treatment to determine its efficacy. The trial aims to provide an alternative to traditional pharmacological and non-pharmacological interventions that often have limited effectiveness.

Who should consider this trial

Good fit: Ideal candidates are French-speaking stroke survivors aged 18 to 75 who have been diagnosed with spasticity at least three months post-stroke.

Not a fit: Patients who are pregnant, have contraindications for using the EXOPULSE Mollii suit, or are involved in other research protocols may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve mobility and quality of life for stroke survivors suffering from spasticity.

How similar studies have performed: While the use of non-invasive techniques for managing spasticity is gaining interest, the specific application of the EXOPULSE Mollii Suit in this context is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

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 ".)

Where this trial is running

Creteil, Val de Marne

• Clinical Neurophysiology department, Henri Mondor Hospital, Creteil, France — Creteil, Val de Marne, France (RECRUITING)

Study contacts

• Principal investigator: Samar S AYACHE, MD, PhD — Clinical Neurophysiology department, Henri Mondor Hospital, Creteil, France
• Study coordinator: Samar S AYACHE, MD, PhD

Conditions: Spasticity As Sequela of Stroke, EXOPULSE Mollii Suit, Motor Functions &amp, amp, Stroke, Spasticity