nctId: NCT06386510 id: 2025-5517 briefTitle: Cranial Nerve Neuromodulation to Improve Arm Function and Brain Plasticity in Stroke acronym: CN-NINM overallStatus: NOT_YET_RECRUITING date: 2024-11-01 date: 2027-05-01 date: 2027-07-01 date: 2024-04-26 date: 2024-04-29 name: Université de Sherbrooke class: OTHER 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. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: multicentered stratified randomized controlled trial primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 74 type: ESTIMATED name: Strength training name: Cranial nerve non-invasive neuromodulation measure: Change in UL motor function on the Fugl-Meyer Stroke Assessment Scale measure: Change in UL functional performance on the Wolf Motor Function Test measure: Change in motor cortex excitability by means of resting MEP amplitudes elicited by TMS over both hemispheres. measure: Change in participants' subjective real life functional UL performance on the Motor Activity Log measure: Change in active and passive range of motion at both UL in shoulder flexion, elbow flexion and wrist extension measure: Change in resting motor threshold of the affected and unaffected FDI sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT 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 name: Marie-Helene Boudrias, PhD role: CONTACT phone: 514-398-5457 email: mh.boudrias@mcgill.ca name: Marie-Helene Boudrias, PhD role: PRINCIPAL_INVESTIGATOR lat: 45.56995 lon: -73.692 facility: Centre de recherche sur le vieillissement city: Sherbrooke state: Quebec zip: J1H 4C4 country: Canada name: Marie-Helene Milot, PhD role: CONTACT phone: 819-780-2220 phoneExt: 45277 email: marie-helene.milot@usherbrooke.ca name: Maureen Ahiatsi, MsC role: CONTACT phone: 819-780-2220 phoneExt: 45691 email: maureen.rudy.sandra.ahiatsi@usherbrooke.ca lat: 45.40008 lon: -71.89908 facility: CIRRIS city: Québec zip: G1M2S8 country: Canada name: Andréanne Blanchette, PhD role: CONTACT phone: 418-529-9141 phoneExt: 46896 email: andreanne.blanchette@fmed.ulaval.ca name: Andréanne Blanchette, PhD role: PRINCIPAL_INVESTIGATOR lat: 46.81228 lon: -71.21454 hasResults: False