Recruiting

Cranial Nerve Neuromodulation

Sponsor:

Université de Sherbrooke

Code:

NCT06386510

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Strength training

Cranial nerve non-invasive neuromodulation

Study Details

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.

Conditions

Stroke

Study ID

NCT06386510

Start date

Jun 2, 2025

Status verified date

May, 2026

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

74 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

Strength training

The strength training program will last 4 weeks (3 X/week, 60 minutes). Using dead weights, the 1RM (i.e. the maximal load that an individual can lift once) will be estimated by the 10RM for the wrist extensors and the elbow and shoulder flexors. The grip muscles of the affected hand will also be trained with a JAMAR® dynamometer. Depending on each participant's intensity training group, training will start at 35%, 50% or 70% of 1RM and will be increased by 5% each week to reach, by week 4, 50%, 65% and 85%, for the low, moderate, and high-intensity group, respectively.

Cranial nerve non-invasive neuromodulation

For the first 20 minutes of each training session, CN-NINM will be applied (50 μsec at 150 Hz), using a portable stimulator (Cthulhu Shield, USA) with a network of 18 electrodes, directly on the participants' tongue. The participants will hold the device in place by pressing their tongue upwards and the intensity of the stimulus will be set by each participant to a comfortable level of sensation (experimental group) or set by a trainer to a non-perceivable stimulus (control group).

Primary outcome measure

  • Change in UL motor function on the Fugl-Meyer Stroke Assessment Scale [ Time Frame: The assessments will be done at the baseline and in the week after completion of the training program and CN-NINM ]
  • Change in UL functional performance on the Wolf Motor Function Test [ Time Frame: The assessments will be done at the baseline and in the week after completion of the training program and CN-NINM. ]
  • Change in motor cortex excitability by means of resting MEP amplitudes elicited by TMS over both hemispheres. [ Time Frame: The assessments will be done at the baseline and in the week after completion of the training program and CN-NINM. ]

Central Contacts and Locations

Locations

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

Recruiting

Laval, Quebec, Canada, H7V 1R2

Contacts

Marie-Helene Boudrias, PhD

514-398-5457mh.boudrias@mcgill.ca

Principal Investigator:

Marie-Helene Boudrias, PhD

CIRRIS

Recruiting

Québec, Quebec, Canada, G1M2S8

Contacts

Principal Investigator:

Andréanne Blanchette, PhD

Centre de recherche sur le vieillissement

Recruiting

Sherbrooke, Quebec, Canada, J1H 4C4

Contacts

More Information

Sponsor

Université de Sherbrooke

Last update posted

May 8, 2026

Last verified

May, 2026

Keywords

  • Cranial nerve non-invasive neuromodulation
  • Brain plasticity
  • Recovery
  • Strength training
  • Transcranial magnetic stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2026-05-08.