EXOPULSE Mollii Suit, Motor Function & Stroke (EXOSTROKE)

NCT06702163 | Completed

• 1 other identifier: 2022-A00232-41
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Spasticity as Sequela of Stroke

Keywords

EXOPULSE Mollii Suit; Motor Functions & Stroke; Spasticity

Outcome Measures

Primary Outcomes (1)

• Improvement in balance using the BBS (Berg Balance Scale) ) before and after active and sham stimulation

  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.

  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 (8)

• 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

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

Experimental Condition

ACTIVE COMPARATOR

Active sessions will last 1 hour each. The following parameters will be used for electric stimulation: low frequency (20 Hz), low current intensity (2 mA), with a small pulse width of 25-170 microseconds. These parameters were previously found to be safe in human studies. Based on the clinical exam of each patient, the spastic muscles will be targeted. EXOPULSE Mollii Suit is used for activation of weak muscles or relaxation of spastic muscles mediated by a physiological reflex mechanism referred to as reciprocal inhibition. By sending an electrical signal to an antagonistic muscle, the spastic muscle will subsequently relax.

Device: EXOPULSE MOLLII SUIT (active)

Control Condition

SHAM COMPARATOR

In the control condition, the patients will receive a sham stimulation, for which the control unit will be programmed to start stimulating for 1 minute then it will shut off. There is no risk related to the sham intervention since it consists of applying the same parameters used for the active session (low frequency: 20 Hz; current intensity: 2 mA; pulse width ranging from 25 to 170 µs) but for a shorter duration of time (1 minute instead of 1 hour).

Device: EXOPULSE MOLLII SUIT (sham)

Interventions

EXOPULSE MOLLII SUIT (active) DEVICE

Exopulse Mollii suit is a new assistive device that has been developed by Exoneural Network (initially Inerventions AB), a Swedish med-tech company. Exopulse Mollii suit is a full-body garment with integrated 58 electrodes that can transcutaneously stimulate several groups of muscles. This stimulation is not intended to obtain a motor effect (contraction of the muscles in question), but rather to decrease the spasticity in spastic muscles by activating the antagonistic muscles via the physiological mechanism of reciprocal inhibition. The device is CE labelled and is intended to use for reducing spasticity and improving blood circulation. The outfit is very easy to put on, it can be used for one hour every day and the analgesic effects last 24 hours or more.

Experimental Condition

EXOPULSE MOLLII SUIT (sham) DEVICE

In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off.

Control Condition

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Having a Berg Balance Scale score ≤46 associated across the literature with a risk of fall.

You may not qualify if:

• 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 ".)

Sponsors & Collaborators

• Institut De La Colonne Vertebrale Et Des Neurosciences: lead

Study Sites (1)

Clinical Neurophysiology department, Henri Mondor Hospital, Creteil, France

Créteil, VAL DE MARNE, 94000, France

Location

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Samar S AYACHE, MD, PhD

  Clinical Neurophysiology department, Henri Mondor Hospital, Creteil, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: November 22, 2024
• Study Start: December 20, 2022
• Primary Completion: April 2, 2025
• Study Completion: April 17, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

FR (1)