Cranial Nerve Neuromodulation to Improve Arm Function and Brain Plasticity in Stroke - Trial NCT06386510
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Study Focus
Sponsor & Location
Université de Sherbrooke
Timeline & Enrollment
N/A
Nov 01, 2024
Jul 01, 2027
Primary Outcome
Change in UL motor function on the Fugl-Meyer Stroke Assessment Scale,Change in UL functional performance on the Wolf Motor Function Test,Change in motor cortex excitability by means of resting MEP amplitudes elicited by TMS over both hemispheres.
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06386510
Non-Device Trial