Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT06386510

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

Led by Université de Sherbrooke · Updated on 2026-05-08

74

Participants Needed

3

Research Sites

112 weeks

Total Duration

On this page

Sponsors

U

Université de Sherbrooke

Lead Sponsor

H

Heart and Stroke Foundation of Canada

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be 18 years of age or older
  • Have had a unilateral supratentorial stroke
  • Be in the chronic stage of recovery, more than 6 months after stroke
  • Have some upper limb motor recovery with a Fugl-Meyer Stroke Assessment score of 25 or higher out of 66
  • Not be currently involved in rehabilitation treatments
Not Eligible

You will not qualify if you...

  • Have significant spasticity in the upper limb with a score over 3 on the modified Ashworth scale
  • Have major sensory deficits in the upper limb with low scores on the Nottingham sensory assessment and vibration threshold tests
  • Have hemineglect affecting more than 70% of lines on the affected side on the Line Cancellation test
  • Have apraxia with a score over 2.5 on the Alexander test
  • Have neurological disorders other than stroke
  • Have orthopedic problems affecting the upper limb
  • Have cognitive impairment with a Mini-Cog score below 2 out of 5
  • Have significant pain in the upper limb with a score of 6 or higher out of 10 on the Visual Analog Pain Scale
  • Have absence of motor evoked potentials with peak-to-peak amplitude below 20 microvolts
  • Have contraindications to cranial nerve non-invasive neuromodulation or transcranial magnetic stimulation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

CRIR/Feil/Oberfeld Research Center; Centre intégré de santé et de services sociaux de Laval; Jewish Rehabilitation Hospital

Laval, Quebec, Canada, H7V 1R2

Actively Recruiting

2

CIRRIS

Québec, Quebec, Canada, G1M2S8

Actively Recruiting

3

Centre de recherche sur le vieillissement

Sherbrooke, Quebec, Canada, J1H 4C4

Actively Recruiting

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Research Team

M

Marie-Helene Milot, PhD

CONTACT

M

Maureen Ahiatsi, MsC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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