NCT06702163

EXOPULSE Mollii Suit, Motor Function & Stroke (EXOSTROKE)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Institut De La Colonne Vertebrale Et Des Neurosciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	EXOPULSE MOLLII SUIT (active)	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.
DEVICE	EXOPULSE MOLLII SUIT (sham)	In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off.

Timeline

• Start date: 2022-12-20
• Primary completion: 2025-04-02
• Completion: 2025-04-17
• First posted: 2024-11-22
• Last updated: 2026-02-27

Locations

1 site across 1 country: France