Clinical trial NCT06266286: EXOPULSE Mollii Suit & Cerebral Palsy
Official title: The Effects of EXOPULSE Mollii Suit on Motor Functions in Children With Cerebral Palsy (EXOCEP): A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Keywords: Spasticity
Motor Functions
Quality of life
Lead sponsor: Institut De La Colonne Vertebrale Et Des Neurosciences
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 32
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The investigators designes a randomized crossover, sham-controlled, double- blind trial to demonstrate the improvement of motor functions and cerebral palsy related symptoms following two weeks of daily sessions of "active" versus "sham" EXOPULSE Mollii suit. A two-week washout period should be enough to prevent a potential carry- over effect.

Two weeks after the end of this phase (phase 1), a second phase of this trial, an open label phase, will be proposed for all patients to understand the effects of EXOPULSE Mollii suit and will consist of six months of active stimulation (sessions performed on a daily basis with the same parameters used for the active session in phase 1) on cerebral palsy related symptoms.

Summary:

* Phase 1: randomized sham controlled crossover study (active versus sham condition)
* Phase 2: Open label study (active condition)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement in balance using the PBS (Pédiatric Balance Scale) before and after active and sham stimulation
timeFrame: This will be assessed at baseline (day 1), 2 weeks, 4 weeks, 6 weeks and 8 weeks
Secondary outcomes:
measure: Evaluation of the cumulative effects of EXOPULSE Mollii suit on balance using the PBS
timeFrame: This will be assessed at 8 weeks, at 12 weeks, and at 32 weeks of using EXOPULSE Mollii suit
measure: Evaluation of the effects of EXOPULSE Mollii suit on spasticity using the Modified Ashworth Scale (MAS)
timeFrame: 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
measure: Evaluation of the effects of EXOPULSE Mollii suit on mobility using the Timed Up and Go test (TUG)
timeFrame: 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
measure: Quality of life will be measured using the EuroQol 5 dimensions quality of life questionnaire for youth (EQ-5D-Y)
timeFrame: 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
measure: Pain will be assessed using the Pain Scale Chart (PSC)
timeFrame: 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
measure: Evaluation of overall improvement using the Clinical Global Impression (CGI)
timeFrame: 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
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Centre Hospitalier Intercommunal D'Aix Pertuis
city: Lyon
country: France
facility: Centre Medico Chirurgical de Readaptation Des Massues
city: Nice
country: France
facility: Centre de Sante Rossetti
city: Saint-Trojan-les-Bains
country: France
facility: Centre de Readaptation Pediatrique D'Oleron
Study officials:
affiliation: Clinical Neurophysiology department, Henri Mondor Hospital, Creteil, France
name: Samar S AYACHE, MD, PhD
role: STUDY_DIRECTOR
References: