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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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

Locations
Other Locations
France
Clinical Neurophysiology department, Henri Mondor Hospital, Creteil, France
RECRUITING
Créteil
Contact Information
Primary
Samar S AYACHE, MD, PhD
samarayache@gmail.com
+33 149814662
Backup
Moussa A CHALAH, MD, PhD
moussachalah@gmail.com
Time Frame
Start Date: 2022-05-01
Estimated Completion Date: 2024-11-30
Participants
Target number of participants: 34
Treatments
Active_comparator: Experimental Condition
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.
Sham_comparator: Control Condition
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).
Sponsors
Leads: Institut De La Colonne Vertebrale Et Des Neurosciences

This content was sourced from clinicaltrials.gov