EXOPULSE Mollii Suit, Motor Function & Stroke (EXOSTROKE)

Institut De La Colonne Vertebrale Et Des Neurosciences

Status: Enrolling

Conditions: Spasticity As Sequela of Stroke

Treatments: Device: EXOPULSE MOLLII SUIT (sham); Device: EXOPULSE MOLLII SUIT (active)

Study type: Interventional

Funder types: Other

Identifiers

NCT06702163

2022-A00232-41

Details and patient eligibility

About

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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 ".)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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34 participants in 2 patient groups

Experimental Condition

Active Comparator group

Description:

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.

Treatment:

Device: EXOPULSE MOLLII SUIT (active)

Control Condition

Sham Comparator group

Description:

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).

Treatment:

Device: EXOPULSE MOLLII SUIT (sham)