protocolSection identificationModule nctId: NCT06266286, orgStudyIdInfo id: 2022-A00233-40, briefTitle: EXOPULSE Mollii Suit & Cerebral Palsy, acronym: EXOCEP, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-13, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-10-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Institut De La Colonne Vertebrale Et Des Neurosciences, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Cerebral Palsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: 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), primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: EXOPULSE MOLLII SUIT (active), interventions name: EXOPULSE MOLLII SUIT (sham), outcomesModule primaryOutcomes measure: Improvement in balance using the PBS (Pédiatric Balance Scale) before and after active and sham stimulation, secondaryOutcomes measure: Evaluation of the cumulative effects of EXOPULSE Mollii suit on balance using the PBS, secondaryOutcomes measure: Evaluation of the effects of EXOPULSE Mollii suit on spasticity using the Modified Ashworth Scale (MAS), secondaryOutcomes measure: Evaluation of the effects of EXOPULSE Mollii suit on mobility using the Timed Up and Go test (TUG), secondaryOutcomes measure: Quality of life will be measured using the EuroQol 5 dimensions quality of life questionnaire for youth (EQ-5D-Y), secondaryOutcomes measure: Pain will be assessed using the Pain Scale Chart (PSC), secondaryOutcomes measure: Evaluation of overall improvement using the Clinical Global Impression (CGI), eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Centre Hospitalier Intercommunal D'Aix Pertuis, status: RECRUITING, city: Aix-en-Provence, country: France, contacts name: PASCAL GRANIER, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: HELENE RAUSCENT, MD, role: SUB_INVESTIGATOR, geoPoint lat: 43.5283, lon: 5.44973, locations facility: Centre Medico Chirurgical de Readaptation Des Massues, status: NOT_YET_RECRUITING, city: Lyon, country: France, contacts name: EMMANUELLE CHALEAT - VALAYER, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Marie-Charlotte D'ANJOU, MD, role: SUB_INVESTIGATOR, geoPoint lat: 45.74848, lon: 4.84669, locations facility: Centre de Sante Rossetti, status: RECRUITING, city: Nice, country: France, contacts name: GAUTIER DE CHELLE, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70313, lon: 7.26608, locations facility: Centre de Readaptation Pediatrique D'Oleron, status: RECRUITING, city: Saint-Trojan-les-Bains, country: France, contacts name: SOLENE VIOT, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.84134, lon: -1.20728, hasResults: False