protocolSection identificationModule nctId: NCT06386510, orgStudyIdInfo id: 2025-5517, briefTitle: Cranial Nerve Neuromodulation to Improve Arm Function and Brain Plasticity in Stroke, acronym: CN-NINM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-11-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2027-07-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Université de Sherbrooke, class: OTHER, descriptionModule briefSummary: Following a stroke, persistent residual muscle weakness in the upper limb (UL) drastically impacts the individuals' quality of life and level of independence. Training interventions are recommended to promote UL motor recovery, and recent studies have shown that training must be tailored to each individual's recovery potential to maximise training gains. Complementary to training interventions, non-invasive brain stimulation devices (NIBS) can help support the provision of post-stroke care by modulating brain excitability and enhancing recovery. Among NIBS, cranial nerve non-invasive neuromodulation (CN-NINM) is gaining increasing attention in rehabilitation since it can directly and non-invasively stimulate the tongue's cranial nerves. The impulses generated can then reach the motor cortex, induce neuroplastic changes and support recovery. Promising results in various neurological populations have been observed, but in stroke, the efficacy of CN-NINM at improving arm motor recovery and brain plasticity is yet to be determined. This is what the present project intends to address, using a stratified randomized controlled trial, where participants in the chronic phase of a stroke will take part in a 4-week individualized training program of their affected UL in combination with real or sham CN-NINM. Before and after the intervention, participants will undergo clinical and neurophysiological evaluations to thoroughly evaluate CN-NINM-induced changes in UL motor function and associated neuroplastic changes. The proposed study will allow an in-depth evaluation of the effects of CN-NINM for an eventual implementation in clinics and at home to support optimal post-stroke recovery., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: multicentered stratified randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 74, type: ESTIMATED, armsInterventionsModule interventions name: Strength training, interventions name: Cranial nerve non-invasive neuromodulation, outcomesModule primaryOutcomes measure: Change in UL motor function on the Fugl-Meyer Stroke Assessment Scale, primaryOutcomes measure: Change in UL functional performance on the Wolf Motor Function Test, primaryOutcomes measure: Change in motor cortex excitability by means of resting MEP amplitudes elicited by TMS over both hemispheres., secondaryOutcomes measure: Change in participants' subjective real life functional UL performance on the Motor Activity Log, secondaryOutcomes measure: Change in active and passive range of motion at both UL in shoulder flexion, elbow flexion and wrist extension, secondaryOutcomes measure: Change in resting motor threshold of the affected and unaffected FDI, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CRIR/Feil/Oberfeld Research Center; Centre intégré de santé et de services sociaux de Laval; Jewish Rehabilitation Hospital, city: Laval, state: Quebec, zip: H7V 1R2, country: Canada, contacts name: Marie-Helene Boudrias, PhD, role: CONTACT, phone: 514-398-5457, email: mh.boudrias@mcgill.ca, contacts name: Marie-Helene Boudrias, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.56995, lon: -73.692, locations facility: Centre de recherche sur le vieillissement, city: Sherbrooke, state: Quebec, zip: J1H 4C4, country: Canada, contacts name: Marie-Helene Milot, PhD, role: CONTACT, phone: 819-780-2220, phoneExt: 45277, email: marie-helene.milot@usherbrooke.ca, contacts name: Maureen Ahiatsi, MsC, role: CONTACT, phone: 819-780-2220, phoneExt: 45691, email: maureen.rudy.sandra.ahiatsi@usherbrooke.ca, geoPoint lat: 45.40008, lon: -71.89908, locations facility: CIRRIS, city: Québec, zip: G1M2S8, country: Canada, contacts name: Andréanne Blanchette, PhD, role: CONTACT, phone: 418-529-9141, phoneExt: 46896, email: andreanne.blanchette@fmed.ulaval.ca, contacts name: Andréanne Blanchette, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.81228, lon: -71.21454, hasResults: False