EXOPULSE Mollii Suit & Cerebral Palsy (EXOCEP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: EXOPULSE MOLLII SUIT (active); Device: EXOPULSE MOLLII SUIT (sham)

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 Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samar S AYACHE, MD, PhD; Phone Number: 0149814662; Email: samarayache@gmail.com
• Study Contact Backup: Name: Moussa A CHALAH, MD, PhD; Email: moussachalah@gmail.com

Study Locations

• France
  • Aix-en-Provence, France
    • Recruiting
    • Centre Hospitalier Intercommunal D'Aix Pertuis
    • Principal Investigator: PASCAL GRANIER, MD
    • Sub-Investigator: HELENE RAUSCENT, MD
  • Lyon, France
    • Not yet recruiting
    • Centre Medico Chirurgical de Readaptation Des Massues
    • Principal Investigator: EMMANUELLE CHALEAT - VALAYER, MD
    • Sub-Investigator: Marie-Charlotte D'ANJOU, MD
  • Nice, France
    • Recruiting
    • Centre de Sante Rossetti
    • Principal Investigator: GAUTIER DE CHELLE, MD
  • Saint-Trojan-les-Bains, France
    • Recruiting
    • Centre de Readaptation Pediatrique D'Oleron
    • Principal Investigator: SOLENE VIOT, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Comparator; 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.	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
Sham Comparator: Sham Comparator; In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in balance using the PBS (Pédiatric Balance Scale) before and after active and sham stimulation	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.	This will be assessed at baseline (day 1), 2 weeks, 4 weeks, 6 weeks and 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the cumulative effects of EXOPULSE Mollii suit on balance using the PBS	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.	This will be assessed at 8 weeks, at 12 weeks, and at 32 weeks of using EXOPULSE Mollii suit
Evaluation of the effects of EXOPULSE Mollii suit on spasticity using the Modified Ashworth Scale (MAS)	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	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
Evaluation of the effects of EXOPULSE Mollii suit on mobility using the Timed Up and Go test (TUG)	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).	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
Quality of life will be measured using the EuroQol 5 dimensions quality of life questionnaire for youth (EQ-5D-Y)	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).	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
Pain will be assessed using the Pain Scale Chart (PSC)	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.	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
Evaluation of overall improvement using the Clinical Global Impression (CGI)	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)	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

Collaborators and Investigators

• Sponsor: Institut De La Colonne Vertebrale Et Des Neurosciences
• Investigators: Study Director: Samar S AYACHE, MD, PhD, Clinical Neurophysiology department, Henri Mondor Hospital, Creteil, France

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): October 30, 2025

Study Registration Dates

• First Submitted: January 16, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Quality of life; Spasticity; Motor Functions
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 2022-A00233-40

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No