NCT06266286

EXOPULSE Mollii Suit & Cerebral Palsy

The Effects of EXOPULSE Mollii Suit on Motor Functions in Children With Cerebral Palsy (EXOCEP): A Pilot Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Institut De La Colonne Vertebrale Et Des Neurosciences · Academic / Other
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

Spasticity is a frequent and debilitating symptom in patients with cerebral palsy. It can alter the patients' balance, mobility, as well as their quality of life (QoL). The available therapeutic strategies for treating spasticity and related symptoms are usually faced with limited efficacy and numerous side effects. For these reasons, non-invasive stimulation techniques, namely transcutaneous electric nerve stimulation using EXOPULSE Mollii suit, might be of help in this context.

Detailed description

This work will assess the effects of the EXOPULSE Mollii suit, which is an assistance device applying non-invasive transcutaneous electrostimulation. The EXOPULSE Mollii control unit is a class IIa device, CE marked, and therefore compliant with the Medical Device Directive. Its intended use includes relaxing spastic muscles, maintaining or increasing the range of movement, activating and re-educating muscles, delaying or preventing atrophy due to disuse, increasing local blood flow, and symptomatic relief and management of chronic refractory pain. The available interventions targeting spasticity are faced with some limitations. For instance, botulinum toxin injection does not seem to improve arm and hand capacity, walking, or quality of life. The available oral agents are challenged by their potential side effects, such as sedation, drowsiness, mental confusion, fatigue, ataxia, hallucination, insomnia, nausea, dry mouth, bradycardia, hypotension, and depression, to cite a few. Therefore, developing novel therapies would help to overcome the actual limitations. Transcutaneous Electrical Nerve Stimulation (TENS) has proven some efficacy in spasticity management. However, one should note that practical difficulties could arise when using TENS at home or in clinical practice (i.e., correctly attaching electrodes). To overcome these limitations, the EXOPULSE Mollii suit has been developed by Exoneural Network, a Swedish med-tech company. It represents an innovative approach for non-invasive electro-stimulation to reduce spasticity and improve motor function. EXOPULSE Mollii suits consist of body Garments (Jacket and Pants) and a control unit. The body Garments (Jacket and Pants) is a suit with 58 embedded electrodes that can stimulate 40 groups of muscles, conductive wires, and connectors to a detachable control unit, whose intended purpose is to transmit electric pulses from the control unit to key nerves and corresponding muscle groups throughout the body. The control unit is a battery-powered electrical device that sends low-intensity electric pulses through connectors to the Body Garments which in turn transmits the pulses from the connectors to key nerves and corresponding muscle groups throughout the body. EXOPULSE Mollii suit consists of transcutaneously stimulating the spastic antagonist muscles with an electric current (i.e., low frequency \~20 Hz, low intensity\~2 mA), aiming to reduce muscle stiffness. This treatment method's theoretical background primarily refers to the concept of reciprocal inhibition, i.e., that sensory input from a muscle may inhibit the activation of an antagonistic muscle. Thus, the application of the EXOPULSE Mollii suit aims to stimulate a muscle, e.g., the anterior tibialis muscle to reduce reflex-mediated over-activity (i.e., spasticity) of calf muscles by inducing reciprocal inhibition. There is growing evidence now from pilot applications of EXOPULSE Mollii suit indicating beneficial effects of using this suit on activity (i.e., mobility and gross motor function) and participation.

Conditions

• Cerebral Palsy

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: 2023-09-13
• Primary completion: 2025-06-30
• Completion: 2025-10-30
• First posted: 2024-02-20
• Last updated: 2024-02-20

Locations

4 sites across 1 country: France