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Cranial Nerve Neuromodulation to Improve Arm Function and Brain Plasticity in Stroke

Study acronym: CN-NINM
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Start date changed from estimate of Jun 1, 2025 to Jun 2, 2025v5
  2. Notable Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Start date: Mar 1, 2025 to Jun 1, 2025
    • Primary completion date: May 1, 2027 to Aug 1, 2027
    • Study completion date: Jul 1, 2027 to Aug 1, 2027
    • Site details revised at 3 of 3 sites
  3. Notable Start date: Nov 1, 2024 to Mar 1, 2025
    • Collaborators expanded, about 6 words
    v3
  4. Minor Collaborators shortened, about 6 wordsv2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT06386510
Lead Sponsor Université de Sherbrooke
Collaborators: Heart and Stroke Foundation of Canada
Conditions
(from sponsor)
Stroke
Related terms Stroke
Enrollment 74 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov