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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
CRIR/Feil/Oberfeld Research Center; Centre intégré de santé et de services sociaux de Laval; Jewish Rehabilitation Hospital
RECRUITING
Laval
CIRRIS
RECRUITING
Québec
Centre de recherche sur le vieillissement
RECRUITING
Sherbrooke
Contact Information
Primary
Marie-Helene Milot, PhD
marie-helene.milot@usherbrooke.ca
819-780-2220
Backup
Maureen Ahiatsi, MsC
maureen.rudy.sandra.ahiatsi@usherbrooke.ca
819-780-2220
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2027-08-01
Participants
Target number of participants: 74
Treatments
Experimental: real CN-NINM + UL training group
Upper limb strength training program combined to real CN-NINM
Placebo_comparator: sham CN-NINM + UL training group
Upper limb strength training program combined to sham CN-NINM
Related Therapeutic Areas
Sponsors
Leads: Université de Sherbrooke
Collaborators: Heart and Stroke Foundation of Canada

This content was sourced from clinicaltrials.gov