EXOPULSE Mollii Suit, Motor Function & Stroke (EXOSTROKE)

Not Applicable

Recruiting

• Conditions: Spasticity As Sequela of Stroke

• Registration Number: NCT06702163
• Lead Sponsor: Institut De La Colonne Vertebrale Et Des Neurosciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-01
• Status Verified: 2024-02
• Primary Completion: 2024-10-31
• Study First Submitted: 2024-11-03
• Study First Submitted QC: 2024-11-20
• Last Update Submitted: 2024-11-20
• Study First Posted: 2024-11-22
• Last Update Posted: 2024-11-22
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

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

• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Improvement in balance using the BBS (Berg Balance Scale) ) before and after active and sham stimulation	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)	Balance will be assessed using the 14-item BBS which has good psychometric properties in patients with stroke. The scale rates the balance using 56 points, with higher scores indicating better balance abilities. A score equal to or below 45 is commonly associated with the risk of falls across the literature.

Secondary Outcome Measures

Name	Time	Method
Assessment of the cumulative effects of EXOPULSE Mollii suit on balance using the BBS (Berg Balance Scale)	Evaluation will occur before Visit 5 (Day 60) and after Visit 6 (Day 90) 4 weeks of using EXOPULSE Mollii suit	The cumulative effects of EXOPULSE Mollii Suit will be assessed following 4 weeks of using the device (3-4 times per week, during the open-label phase 2)
Assessment of the spasticity using the MAS (Modified Ashworth Scale) and the VAS pain (Visual Analogue Scale)	This will be assessed through study completion, an average of 3 months (at Visits 1, 2, 3, 4, 5 and 6)	Spasticity will be evaluated by examiners using the MAS (Modified Ashworth Scale) and by patients using a VAS (Visual Analogue Scale)
Mobility will be assessed using the TUG scale (Time Up and Go)	This will be assessed through study completion, an average of 3 months (at Visits 1, 2, 3, 4, 5 and 6)	TUG (Time Up and Go)is a validated test in patients with stroke. The score is expressed as the time (in seconds) required to perform sequential motor tasks (standing up from the chair, walking to the line on the floor at a normal pace, turning, walking back to the chair at a normal pace and finally sitting down).
Mobility will be assessed using the FES-I (Falls Efficacy Scale-International scale)	Evaluation will occur before Visit 5 (Day 60) and after Visit 6 (Day 90) 4 weeks of using EXOPULSE Mollii suit (Phase 2)	Subjective risk of fall will be assessed using the French version of the Falls Efficacy Scale-International scale (FES-I) ; a 14-item scale that assesses the perceived risk of falling.
Quality of life will be measured using the EQ-5D-5L (EuroQol 5 Dimensions 5 Levels Quality of Life Questionnaire)	Evaluation will occur before Visit 5 (Day 60) and after Visit 6 (Day 90) 4 weeks of using EXOPULSE Mollii suit (Phase 2)	This variable will be measured using the EuroQol 5 dimensions quality of life questionnaire, a scale developed by EuroQoL group. This scale has good psychometric properties in stroke and seems to be the most used generic health status questionnaire in this population. The 5 levels version (EQ-5D-5L) will be adopted in this work. The scale evaluates five dimensions: anxiety/depression, mobility, pain/difficulty, self-care, and usual activities.
Pain and fatigue will be assessed using a VAS (Visual Analogue Scale)	This will be assessed through study completion, an average of 3 months (at Visit 1, V2, V3, V4, V5 and V6)	The visual analog scale for pain is a 10 mm straight line with one end meaning no pain and the other end meaning the worst pain imaginable
Evaluation of overall improvement using the CGI (Clinical Global Impression)	This will be assessed at Visit2 (Day 15) , Visit4 (Day 45) and Visit6 (Day 90) since CGI is designed to be applied after interventions	It consists of 7-point scale ranging from "very much improved since the initiation of treatment" to "very much worse since the initiation of treatment" (from 1 to 7)
Evaluation of patient's blinding to the type of stimulation in the crossover trial	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)	This blind evaluation will be done in phase 1 using a dedicated questionnaire (only at visits 2 and 4 after each condition, as all patients will receive the same active treatment during open-label phase 2).

Trial Locations

Locations (1)

Clinical Neurophysiology department, Henri Mondor Hospital, Creteil, France; 🇫🇷 Creteil, Val de Marne, France