NCT06386510 Cranial Nerve Neuromodulation to Improve Arm Function and Brain Plasticity in Stroke
| NCT ID | NCT06386510 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Université de Sherbrooke |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 74 participants |
| Start Date | 2025-06-02 |
| Primary Completion | 2027-08-01 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 74 participants in total. It began in 2025-06-02 with a primary completion date of 2027-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * be ≥18 years of age; * have had a unilateral supratentorial stroke; * be in a chronic stage of recovery (\>6 months); * present some UL motor recovery (Fugl-Meyer Stroke Assessment \[FMA-UE\] score ≥25/66); * are not involved in rehabilitation treatments. Exclusion Criteria: * significant spasticity at UL (score \>3 on the modified Ashworth scale); * major sensory deficit at UL (a score \<25/34 on the Nottingham sensory assessment and a score \<6 on the vibration threshold assessment); * hemineglect (\> 70% of unshaded lines on the same side as the motor deficit on the Line Cancellation test); * apraxia (score \>2.5 on the Alexander test); * a neurological disorder other than stroke-related; * orthopedic problems at UL; * cognitive impairment (score \<2/5 on the Mini-Cog); * significant pain intensity at UL (a score ≥ 6/10 on the Visual Analog Pain Scale); * absence of MEP (peak-to-peak MEP amplitude \<20μV); * contraindications to CN-NINM and TMS.
Contact & Investigator
Marie-Helene Milot, PhD
PRINCIPAL INVESTIGATOR
Université de Sherbrooke
Frequently Asked Questions
Who can join the NCT06386510 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06386510 currently recruiting?
Yes, NCT06386510 is actively recruiting participants. Contact the research team at marie-helene.milot@usherbrooke.ca for enrollment information.
Where is the NCT06386510 trial being conducted?
This trial is being conducted at Laval, Canada, Québec, Canada, Sherbrooke, Canada.
Who is sponsoring the NCT06386510 clinical trial?
NCT06386510 is sponsored by Université de Sherbrooke. The principal investigator is Marie-Helene Milot, PhD at Université de Sherbrooke. The trial plans to enroll 74 participants.
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