Cranial Nerve Neuromodulation to Improve Arm Function and Brain Plasticity in Stroke (NCT06386510)
Can Stimulating the Tongue Help Improve Upper Limb Motor Function and Brain Plasticity in Individuals at the Chronic Stage of a Stroke: a Randomized Controlled Trial
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: CRIR/Feil/Oberfeld Research Center; Centre intégré de santé et de services sociaux de Laval; Jewish Rehabilitation Hospital — Laval, Quebec
Age range: 18 Years to 85 Years
🧪 Interventions in This Study
- Strength training (PROCEDURE)
- Cranial nerve non-invasive neuromodulation (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (3 Sites)
- CRIR/Feil/Oberfeld Research Center; Centre intégré de santé et de services sociaux de Laval; Jewish Rehabilitation Hospital — Laval, Quebec
- CIRRIS — Québec, Quebec
- Centre de recherche sur le vieillissement — Sherbrooke, Quebec
📞 Contact the Study Coordinator
Phone: (819) 780-2220
Email: marie-helene.milot@usherbrooke.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Stroke
- Validation of a Spasticity Measurement Tool — Chicago, Illinois
- GaitBetter: Motor and Cognitive Training for Gait Rehabilitation and Falls Prevention in Stroke Survivors. — Boston, Massachusetts
- Determining the Optimal Dose of Reactive Balance Training After Stroke — Toronto, Ontario
- AMPLATZER PFO Occluder Post Approval Study — Birmingham, Alabama
- Reflex Excitability in Post-stroke Stiff-Knee Gait — Cleveland, Ohio
- Group Lifestyle Balance™ for Individuals With Stroke (GLB-CVA) — Dallas, Texas
Explore by condition: All Stroke clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.