Clinical trial NCT06702163: EXOPULSE Mollii Suit, Motor Function & Stroke (EXOSTROKE)
Official title: The Effects of EXOPULSE Mollii Suit on Motor Functions in Patients with Stroke (EXOSTROKE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spasticity As Sequela of Stroke
Keywords: EXOPULSE Mollii Suit
Motor Functions &amp;amp; Stroke
Spasticity
Lead sponsor: Institut De La Colonne Vertebrale Et Des Neurosciences
Sponsor class: OTHER
First posted: 2024-11-22
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: We designed a randomized crossover, sham-controlled, double blind trial to demonstrate the improvement of motor functions and stroke related symptoms following a single session of "active" versus "sham" EXOPULSE Mollii suit. A 2-week washout period should be enough to prevent a potential carry over effect.

Two weeks after the end of this phase (phase 1), a second phase of this trial, an open label phase, will be proposed for all patients to understand the effects of EXOPULSE Mollii suit employed over 4 weeks (a session every other day for a total of 14 sessions) on stroke related symptoms.

Summary:

* Phase 1: randomized sham-controlled crossover study (active versus sham condition)
* Phase 2: Open-label study (active condition)
Primary purpose: TREATMENT

Brief summary: 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 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 ".)

Primary outcomes:
measure: Improvement in balance using the BBS (Berg Balance Scale) ) before and after active and sham stimulation
timeFrame: This will be assessed before and after each condition (phase 1, 1 session per condition sham or active stimulation) on Day 0 (Visit1), Day 15 (Visit2), Day 30 (Visit3) and Day 45 (Visit4)
Secondary outcomes:
measure: Assessment of the cumulative effects of EXOPULSE Mollii suit on balance using the BBS (Berg Balance Scale)
timeFrame: Evaluation will occur before Visit 5 (Day 60) and after Visit 6 (Day 90) 4 weeks of using EXOPULSE Mollii suit
measure: Assessment of the spasticity using the MAS (Modified Ashworth Scale) and the VAS pain (Visual Analogue Scale)
timeFrame: This will be assessed through study completion, an average of 3 months (at Visits 1, 2, 3, 4, 5 and 6)
measure: Mobility will be assessed using the TUG scale (Time Up and Go)
timeFrame: This will be assessed through study completion, an average of 3 months (at Visits 1, 2, 3, 4, 5 and 6)
measure: Mobility will be assessed using the FES-I (Falls Efficacy Scale-International scale)
timeFrame: Evaluation will occur before Visit 5 (Day 60) and after Visit 6 (Day 90) 4 weeks of using EXOPULSE Mollii suit (Phase 2)
measure: Quality of life will be measured using the EQ-5D-5L (EuroQol 5 Dimensions 5 Levels Quality of Life Questionnaire)
timeFrame: Evaluation will occur before Visit 5 (Day 60) and after Visit 6 (Day 90) 4 weeks of using EXOPULSE Mollii suit (Phase 2)
measure: Pain and fatigue will be assessed using a VAS (Visual Analogue Scale)
timeFrame: This will be assessed through study completion, an average of 3 months (at Visit 1, V2, V3, V4, V5 and V6)
measure: Evaluation of overall improvement using the CGI (Clinical Global Impression)
timeFrame: This will be assessed at Visit2 (Day 15) , Visit4 (Day 45) and Visit6 (Day 90) since CGI is designed to be applied after interventions
measure: Evaluation of patient's blinding to the type of stimulation in the crossover trial
timeFrame: This will only be assessed at Visit2 (Day 15) and Visit4 (Day 45) since it's designed to be applied after interventions of phase 1 (double blind phase)
Other outcomes:
Locations:
city: Creteil
country: France
facility: Clinical Neurophysiology department, Henri Mondor Hospital, Creteil, France
state: Val de Marne
Study officials:
affiliation: Clinical Neurophysiology department, Henri Mondor Hospital, Creteil, France
name: Samar S AYACHE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: