EXOPULSE Mollii Suit & Cerebral Palsy

Not Applicable

Recruiting

• Conditions: Cerebral Palsy
• Interventions: Device: EXOPULSE MOLLII SUIT (sham); Device: EXOPULSE MOLLII SUIT (active)

• Registration Number: NCT06266286
• Lead Sponsor: Institut De La Colonne Vertebrale Et Des Neurosciences

Brief 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.

Study Timeline

• Study Start: 2023-09-13
• Status Verified: 2023-11
• Study First Submitted: 2024-01-16
• Study First Submitted QC: 2024-02-15
• Last Update Submitted: 2024-02-15
• Study First Posted: 2024-02-20
• Last Update Posted: 2024-02-20
• Primary Completion: 2025-06-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Age between 5 and 12 years.
• Having a clinical diagnosis of unilateral or bilateral spastic cerebral palsy since at least one month.
• Being able to walk freely, with slight limitation or using ancillary equipment's (Gross Motor Function Classification System (GMFCS) score ≤3).
• Having a PBS score < 45.
• Being French speaker, able to understand verbal instructions, and affiliated to the national health insurance (sécurité sociale).
• Having spasticity with a score of at least 1+ on the MAS

Exclusion Criteria

• Being included in another research protocol during the study period
• Being unable to undergo medical monitor for the study purposes due to geographical or social reasons
• Having contraindications to wearing EXOPULSE Mollii suit (i.e., implanted electronic medical devices or equipments which can be disrupted by magnets including ventriculoperitoneal shunts and intrathecal baclofen pumps, electronic life support equipment or high-frequency operation equipment, as well as well electrocardiography equipment or cardiac stimulator)
• Having a change in the pharmacological therapy over the last three months
• Suffering from other somatic or neuropsychiatric diagnoses (e.g., arrhythmias, uncontrolled epilepsy, diseases causing osteoarticular and muscular pain, skin diseases).
• Suffering from a cutaneous disease
• Using another medical device
• Being part of other protected populations as defined in articles L. 1121-5, L. 1121 6,1121-8 and L. 1122-1-2 of the Public Health Code

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham Comparator	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.
Active Comparator	EXOPULSE MOLLII SUIT (active)	Active stimulation sessions will last 1 hour each. Exopulse Mollii suits consists of a 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 several 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 which 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.

Primary Outcome Measures

Name	Time	Method
Improvement in balance using the PBS (Pédiatric Balance Scale) before and after active and sham stimulation	This will be assessed at baseline (day 1), 2 weeks, 4 weeks, 6 weeks and 8 weeks	Balance will be assessed using the 14-item PBS which has well psychometric properties in pediatric patients with cerebral palsy. The scale rates the balance using 56 points, with higher scores indicating better balance abilities.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the effects of EXOPULSE Mollii suit on spasticity using the Modified Ashworth Scale (MAS)	This will be assessed at Day 1, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, and at 32 weeks of using EXOPULSE Mollii suit	It will be evaluated by examiners using the Modified Ashworth Scale (MAS; scores ranging from 0 to 4 which respectively corresponds to normal muscle tone and rigidity, which has been frequently used in clinical settings to rate muscular tone
Evaluation of overall improvement using the Clinical Global Impression (CGI)	This will be assessed at Day 1, 2 weeks, 4 weeks, 6 weeks, 8 weeks,12 weeks, and at 32 weeks of using EXOPULSE Mollii suit	It's consisting of 7-point scale ranging from "very much improved since the initiation of treatment" to "very much worse since the initiation of treatment" (from 1 to 7)
Pain will be assessed using the Pain Scale Chart (PSC)	This will be assessed at Day 1, 2 weeks, 4 weeks, 6 weeks, 8 weeks,12 weeks, and at 32 weeks of using EXOPULSE Mollii suit	Patients suffering from pain are asked to fill in the Pain Scale Chart (PSC) scored from 0 to 10 for pain. 0 meaning no pain and 10 meaning the worst pain experienced.
Evaluation of the cumulative effects of EXOPULSE Mollii suit on balance using the PBS	This will be assessed at 8 weeks, at 12 weeks, and at 32 weeks of using EXOPULSE Mollii suit	Balance will be assessed using the 14-item PBS which has well psychometric properties in pediatric patients with cerebral palsy. The scale rates the balance using 56 points, with higher scores indicating better balance abilities.
Evaluation of the effects of EXOPULSE Mollii suit on mobility using the Timed Up and Go test (TUG)	This will be assessed at Day 1, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, and at 32 weeks of using EXOPULSE Mollii suit	The score is expressed as the time (in seconds) required to perform sequential motor tasks (standing up from the chair, walking to the line on the floor at a normal pace, turning, walking back to the chair at a normal pace and finally sitting down).
Quality of life will be measured using the EuroQol 5 dimensions quality of life questionnaire for youth (EQ-5D-Y)	This will be assessed at Day 1, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, and at 32 weeks of using EXOPULSE Mollii suit	This variable will be measured using the EuroQol 5 dimensions quality of life questionnaire for youth (EQ-5D-Y), a scale developed by EuroQoL group for the pediatric population and has good psychometric properties in children and adolescent. EQ-5D-Y evaluates five dimensions: anxiety/depression, mobility, pain/difficulty, selfcare, and usual activities. The score of each dimension is calculated by assigning a numerical value to each response level (i.e., 1 for "no problems", 5 for "extreme problems"/"unable to") and summing these values across the five items, resulting in a score raning from 5 (no problems on any dimension) to 25 (extreme problems on all dimensions).

Trial Locations

Locations (4)

Centre Medico Chirurgical de Readaptation Des Massues; 🇫🇷 Lyon, France

Centre de Sante Rossetti; 🇫🇷 Nice, France

Centre de Readaptation Pediatrique D'Oleron; 🇫🇷 Saint-Trojan-les-Bains, France

Centre Hospitalier Intercommunal D'Aix Pertuis; 🇫🇷 Aix-en-Provence, France