Testing Strength training with Cranial nerve non-invasive against a placebo for stroke
Official title: Cranial Nerve Neuromodulation to Improve Arm Function and Brain Plasticity in Stroke
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
- 2 groups
- Sites in Laval, Québec and 1 more city
- Recruiting
Interventions
- Medical procedure
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.
- Medical procedure
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).
Canadian Sites (3)
3 of 3 recruiting
- Recruiting
CRIR/Feil/Oberfeld Research Center; Centre intégré de santé et de services sociaux de Laval; Jewish Rehabilitation Hospital
Laval, Quebec
- Recruiting
CIRRIS
Québec, Quebec
- Recruiting
Centre de recherche sur le vieillissement
Sherbrooke, Quebec
Eligibility Criteria
See who this study is looking for15 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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
- −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.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives one or more of: Strength training and Cranial nerve non-invasive neuromodulation.
Registry label: A: real CN-NINM + UL training group
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives one or more of: Strength training and Cranial nerve non-invasive neuromodulation.
Registry label: B: sham CN-NINM + UL training group
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 85 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 74 people.
The study is currently expected to finish around August 2027.
The main measurement is taken over: The assessments will be done at the baselineBaselineYour starting measurements, taken before treatment begins.Read more → and in the week after completion of the training program and CN-NINM.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Change in UL motor function on the Fugl-Meyer Stroke Assessment Scale — measured over The assessments will be done at the baselineBaselineYour starting measurements, taken before treatment begins.Read more → and in the week after completion of the training program and CN-NINM.
Change in UL functional performance on the Wolf Motor Function Test — measured over 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 — measured over The assessments will be done at the baseline and in the week after completion of the training program and CN-NINM.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06386510 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Strength trainingProcedure
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.
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About Cranial nerve non-invasive neuromodulationProcedure
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).
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 85 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 85 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: The assessments will be done at the baselineBaselineYour starting measurements, taken before treatment begins.Read more → and in the week after completion of the training program and CN-NINM.
The study as a whole is currently expected to finish around 2027-08-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 74 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 3 locations, including: Laval, Quebec, Canada; Québec, Quebec, Canada; Sherbrooke, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.