EXOPULSE Mollii Suit & Cerebral Palsy

NCT06266286 | Unknown

• 1 other identifier: 2022-A00233-40
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 4

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.

Conditions

Cerebral Palsy

Keywords

Spasticity; Motor Functions; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

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)

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)

Interventions

EXOPULSE MOLLII SUIT (active) DEVICE

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

Active Comparator

EXOPULSE MOLLII SUIT (sham) DEVICE

In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off

Sham Comparator

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut De La Colonne Vertebrale Et Des Neurosciences: lead

Study Sites (4)

Centre Hospitalier Intercommunal D'Aix Pertuis

Aix-en-Provence, France

RECRUITING

Centre Medico Chirurgical de Readaptation Des Massues

Lyon, France

NOT YET RECRUITING

Centre de Sante Rossetti

Nice, France

RECRUITING

Centre de Readaptation Pediatrique D'Oleron

Saint-Trojan-les-Bains, France

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Samar S AYACHE, MD, PhD

  Clinical Neurophysiology department, Henri Mondor Hospital, Creteil, France

  STUDY DIRECTOR

Central Study Contacts

Samar S AYACHE, MD, PhD

CONTACT

0149814662; samarayache@gmail.com

Moussa A CHALAH, MD, PhD

CONTACT

moussachalah@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: February 20, 2024
• Study Start: September 13, 2023
• Primary Completion: June 30, 2025
• Study Completion: October 30, 2025
• Last Updated: February 20, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)