StrokeNCT05370274
Using Cranial Nerve Non-invasive Neuromodulation to Improve Pain and Upper Extremity Function After a Stroke
A study testing Strength training intervention and Cranial nerve non-invasive neuromodulation (CN-NINM) in people with Stroke, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
Following a stroke, individuals experience pain in the affected upper limb (UL) and residual weakness in the UL, which impacts their quality of life and performance of activities of daily living. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Strength training intervention and Cranial nerve non-invasive neuromodulation (CN-NINM)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 27 Jun 2022to 21 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be ≥18 years old;
- Have had a single supratentorial stroke;
- Be in a chronic stroke phase (>6 months);
- Present motor recovery in the upper limb (UL) (Fugl-Meyer Stroke Assessment [FMA] score ≥20/66);
- Have completed any rehabilitation treatment.
Who cannot join
- A significant spasticity at the affected upper limb (score > 3 on the modified Ashworth scale);
- A major sensory deficit at the affected upper limb (a score ≤25/34 on the Nottingham Sensory Assessment and a score <6 on the evaluation of the vibration threshold);
- A presence of hemineglect (score ≥±0. 083 on the Line Cancellation test);
- An apraxia (score >2.5 on the Alexander Test);
- The presence of a neurological disorder other than a stroke;
- Concomitant orthopaedic problem at the affected UL;
- Cognitive impairment (Mini-Cog score <2/5) and
- Any contraindication to CN-NINM.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de recherche sur le vieillissement
Sherbrooke, Quebec, J1H4C4
About this study
Official title: Cranial Nerve Non-invasive Neuromodulation to Improve Pain and Upper Extremity Function in Individuals in the Chronic Phase of Stroke: a Pilot Feasibility Study
Following a stroke, individuals experience pain in the affected upper limb (UL) and residual weakness in the UL, which impacts their quality of life and performance of activities of daily living. To overcome these deficits, exercises are a key element to any rehabilitation program and are based on the reorganization capacity of the central nervous system (called neuroplasticity). To optimize the beneficial effects of exercises and potentiate neuroplasticity, non-invasive brain stimulation devices (NIBS) are increasingly used as a complementary therapy post stroke. Among NIBS, a new technique, called cranial nerve non-invasive neuromodulation (CN-NINM), is making its way into stroke rehabilitation since, unlike other NIBS such as tDCS, it allows the generation of a direct flow of neuronal impulses via the stimulation of the tongue. The goal of this project is therefore to investigate CN-NINM to document its feasibility and explore its efficacy at improving motor recovery and reduce pain at the affected UL in chronic stroke patients (> 6 months). CN-NINM will be applied for 20 minutes during each exercise session of the UL (3X/week, 4 weeks). Feasibility data will comprise adherence to CN-NINM, drop out rate and adverse events and UL motor recovery and pain will be assessed before and after the exercise program. At the end of this study, it is expected that it will be feasible to use CN-NINM as an intervention in combination with the exercise program and that it will result in improved motor function and reduced pain in affected UL.
Read the detailed description
Following a stroke, survivors experience pain in the affected upper limb (UL) and residual weakness in the UL, which impacts their quality of life and performance of activities of daily living. Exercises is a key element of any rehabilitation program and is based on the capacity of reorganization of the central nervous system (called neuroplasticity) to allow overcoming stroke deficits. In addition, it is now recognized that in the chronic phase of a stroke, motor and functional gains are still possible following various training programs, such as a strength training program. To optimize the beneficial effects of exercise and potentiate neuroplasticity, non-invasive brain stimulation (NIBS) devices are increasingly used as a complementary therapy. Among NIBS, the most widely used technique is transcranial direct current stimulation (tDCS) that modulates cortical excitability and allows for clinical and functional gains, including recovering in UL motor function and pain. However, over 50% of individuals do not respond as expected to the combination of tDCS and rehabilitation exercises. This can be due to anatomical variability between individuals and electrical current shunting. Thus, to bypass these constraints, a new technique, called cranial nerve non-invasive neuromodulation (CN-NINM), is entering stroke rehabilitation. Unlike other NIBS such as tDCS, it generates a direct flow of neural impulses via tongue stimulation. Studies have shown that priming the motor cortex with CN-NINM during a training program can promote improved balance and gait and increased activation of the motor cortex. Until now, no studies have examined the use of CN-NINM for improving UL function and pain.
Goals: 1) To assess the feasibility of using CN-NINM in chronic stroke survivors; 2) To explore the effectiveness of CN-NINM in improving motor function and reducing pain of the affected upper limb in chronic stroke survivors.
Methods: In this feasibility pilot pre/post intervention study, 12 adults at the chronic phase of a stroke (>6 months) will be recruited. Sociodemographic and stroke-related variables (e.g., age, time since stroke) will be collected to confirm participant eligibility. Prior to training, participants will undergo a clinical evaluation of their affected UL as well as an evaluation of simulated pain at the affected UL. For the latter, the effect of CN-NINM on pain will be evaluated using a tonic thermal experimental pain paradigm. For this, a thermode (hot plate) will be applied to the forearm of the participants before and after a single 20-minute application of CN-NINM. On each occasion, thermal nociceptive stimuli will be induced for 2 minutes on the participants' forearm using the thermode. Although the temperature remains constant for the entire 2 minutes, the participant will be informed that the temperature may increase, decrease, or remain stable during the procedure. The participant will then, at all times, evaluate the intensity of the pain with a visual analogue scale connected to a computer (CoVAS: visual analogue scale from 0 to 100). Afterwards, the participants will take part in a 4-week training program of their affected UL (3X/week, 60-minute duration). During each training session, the CN-NINM will be applied for 20 minutes at an intensity tailored to each participant comfort.
- Conditions
- Stroke
- Being tested
- Strength training intervention, Cranial nerve non-invasive neuromodulation (CN-NINM)
- Keywords
- Exercise, Upper limb, Motor recovery, Pain, Cranial nerve non-invasive neuromodulation
- Medical subject headings
- Stroke, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength training interventionProcedure or surgery
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 in order to avoid tendino-muscular injuries and fatigue. The 10RM will be determined for the muscles playing a key role in the functional performance of the upper limb (the wrist extensors and the elbow and shoulder flexors). In addition, the grip muscles of the affected hand will be trained with a JAMAR® dynamometer. Training will start at 50% of 1RM and progress by 10% each week to reach 80% of 1RM by week 4. The same gradation of intensity will be applied to the grip muscles. The training will begin and end by a 5-minute warm-up and relaxation period comprising of active movements of the trained muscles.
Cranial nerve non-invasive neuromodulation (CN-NINM)Procedure or surgery
During each strength training session, the CN-NINM will be applied, with the help of a portable stimulator comprising a network of 18 electrodes, directly on the tongue of the participants for 20 minutes. The participants will hold the CN-NINM in place by pressing their tongue upwards. The CN-NINM will generate high-frequency pulses (50 μsec to 150 Hz), and the intensity of the stimulus will be set by each participant to a comfortable level of sensation, similar to the sensation in the mouth of a soft drink.
| Study group | Role | What they receive |
|---|---|---|
| strength training intervention | Experimental | Strength training of the affected upper limb in chronic stroke survivors Receives: Procedure: Strength training intervention |
| Cranial nerve non-invasive neuromodulation (CN-NINM) | Experimental | CN-NINM will be applied during each session of the strength training intervention Receives: Procedure: Cranial nerve non-invasive neuromodulation (CN-NINM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate for the project
This outcome will be compiled by the total number of participants recruited, divided by the average number of months recruiting.
Measured: Information will be assessed at the end of the recruitment period, at week 28
Refusal to participate and the reasons
Participants refusal to participate will be assessed by number of participants who declined to participate in the project and the associate reasons
Measured: Information will be assessed throughout the project recruitment period (average of 7 months)
Dropped out rate of the project in percent and the reasons
Dropped out rate will be collected by the number of participants who dropped out of the project divided by the total number of participants recruited X 100%. Reasons for each drop out will also be collected.
Measured: Information will be assessed through project completion, an average of 9 months
Adherence to the intervention (training program and CN-NINM) in percent
Adherence to the intervention will be calculated by the number of training sessions completed out of the total number expected X 100%
Measured: Information will be assessed through study completion, an average of 9 months
Number of participants with CN-NINM-related adverse events as assessed by a questionnaire
Adverse events will be assessed with a questionnaire that will provide a number and percentage of participants who have experienced adverse events as well as allowing collecting information on symptoms that may be related to CN-NINM.
Measured: Information will be be assessed through study completion, an average of 9 months
Secondary outcomes (6)
Change in pain intensity on the CoVAS
Change in pain intensity will be calculated by the difference between the pain felt and reported on the CoVAS (average of the 2 minutes) before and after the single application of CN-NINM. The score on the CoVAS ranges between 0 (no pain) to 100 (maximal pain).
Measured: The assessments will be done at the baseline and just after the 20 minutes of application of the CN-NINM.
Change in UL functional performance on the Wolf Motor Function Test
Change in functional performance of the affected UL will be assessed with the timed score of the Wolf Motor Function Test; comprising 17 tasks. The maximal time allocated to each task is 120 seconds.
Measured: The assessments will be done at the baseline and in the week after completion of the training program and CN-NINM.
Change in UL motor function on the Fugl-Meyer Stroke Assessment Scale
Change in motor function of the affected UL will be assessed using the Fugl-Meyer Stroke Assessment where a score of 66 is equivalent to full motor recovery.
Measured: The assessments will be done at the baseline and in the week after completion of the training program and CN-NINM.
Change in affected grip strength on the JAMAR dynamometer
Change in affected grip strength will be assessed by computing the mean of 3 trials in kilograms on the JAMAR dynamometer.
Measured: The assessments will be done at the baseline and in the week after completion of the training program and CN-NINM.
Change in manual dexterity on the Box and Block test
Change in manual dexterity will be assessed with the Box and Block Test, computing the number of blocks that can be transferred from one compartment to another in 60 seconds.
Measured: The assessments will be done at the baseline and in the week after completion of the training program and CN-NINM.
Change in participants' subjective real life functional UL performance on the Motor Activity Log
Change in participants' self-reported affected UL performance in everyday activities will be assessed with the Motor Activity Log (MAL). The MAL comprises 14 task scored on a 0 to 5 Likert scale, where a score of 5 represents normal quantity and quality of use of affected UL.
Measured: The assessments will be done at the baseline and in the week after completion of the training program and CN-NINM.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start27 Jun 2022
- Primary completion21 Jun 2023
- Study completion21 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- The study model is a pre/post intervention pilot study.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie-Hélène Milot, Université de Sherbrooke
- Investigators
- Marie-Hélène Milot, Ph.D., Principal investigator, Université de SherbrookeGuillaume Léonard, Ph.D., Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370274
- Sponsor's protocol ID
- 2022-4609
- Status last verified
- Feb 2024
- First submitted
- 27 Apr 2022
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators are not planning on sharing individual data to the participants.
Publications
Ahiatsi M, Milot MH, Flaive A, Leonard G. Tasting pain-relief through tongue stimulation: results from a feasibility study looking into the use of cranial nerve non-invasive neuromodulation in healthy individuals and chronic poststroke patients. BMC Neurol. 2026 Jan 2;26(1):72. doi: 10.1186/s12883-025-04498-6.
PubMed 41484860Ahiatsi M, Leonard G, Riesco E, Girard MC, Milot MH. A feasibility study on the use of cranial nerve non-invasive neuromodulation to improve affected arm function in people in the chronic stage of a stroke. BMC Neurol. 2025 May 16;25(1):208. doi: 10.1186/s12883-025-04213-5.
PubMed 40380081
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cranial Nerve Non-invasive Neuromodulation to Improve Pain and Upper Extremity Function in Individuals in the Chronic Phase of Stroke: a Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT05370274
- Acronym / sponsor ID
- 2022-4609
- Conditions
- Stroke
- Keywords
- Exercise, Upper limb, Motor recovery, Pain, Cranial nerve non-invasive neuromodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 21 Jun 2023 (actual)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Following a stroke, individuals experience pain in the affected upper limb (UL) and residual weakness in the UL, which impacts their quality of life and performance of activities of daily living. To overcome these deficits, exercises are a key element to any rehabilitation program and are based on the reorganization capacity of the central nervous system (called neuroplasticity). To optimize the beneficial effects of exercises and potentiate neuroplasticity, non-invasive brain stimulation devices (NIBS) are increasingly used as a complementary therapy post stroke. Among NIBS, a new technique, called cranial nerve non-invasive neuromodulation (CN-NINM), is making its way into stroke rehabilitation since, unlike other NIBS such as tDCS, it allows the generation of a direct flow of neuronal impulses via the stimulation of the tongue. The goal of this project is therefore to investigate CN-NINM to document its feasibility and explore its efficacy at improving motor recovery and reduce pain at the affected UL in chronic stroke patients (> 6 months). CN-NINM will be applied for 20 minutes during each exercise session of the UL (3X/week, 4 weeks). Feasibility data will comprise adherence to CN-NINM, drop out rate and adverse events and UL motor recovery and pain will be assessed before and after the exercise program. At the end of this study, it is expected that it will be feasible to use CN-NINM as an intervention in combination with the exercise program and that it will result in improved motor function and reduced pain in affected UL.
Detailed description
Following a stroke, survivors experience pain in the affected upper limb (UL) and residual weakness in the UL, which impacts their quality of life and performance of activities of daily living. Exercises is a key element of any rehabilitation program and is based on the capacity of reorganization of the central nervous system (called neuroplasticity) to allow overcoming stroke deficits. In addition, it is now recognized that in the chronic phase of a stroke, motor and functional gains are still possible following various training programs, such as a strength training program. To optimize the beneficial effects of exercise and potentiate neuroplasticity, non-invasive brain stimulation (NIBS) devices are increasingly used as a complementary therapy. Among NIBS, the most widely used technique is transcranial direct current stimulation (tDCS) that modulates cortical excitability and allows for clinical and functional gains, including recovering in UL motor function and pain. However, over 50% of individuals do not respond as expected to the combination of tDCS and rehabilitation exercises. This can be due to anatomical variability between individuals and electrical current shunting. Thus, to bypass these constraints, a new technique, called cranial nerve non-invasive neuromodulation (CN-NINM), is entering stroke rehabilitation. Unlike other NIBS such as tDCS, it generates a direct flow of neural impulses via tongue stimulation. Studies have shown that priming the motor cortex with CN-NINM during a training program can promote improved balance and gait and increased activation of the motor cortex. Until now, no studies have examined the use of CN-NINM for improving UL function and pain.
Goals: 1) To assess the feasibility of using CN-NINM in chronic stroke survivors; 2) To explore the effectiveness of CN-NINM in improving motor function and reducing pain of the affected upper limb in chronic stroke survivors.
Methods: In this feasibility pilot pre/post intervention study, 12 adults at the chronic phase of a stroke (>6 months) will be recruited. Sociodemographic and stroke-related variables (e.g., age, time since stroke) will be collected to confirm participant eligibility. Prior to training, participants will undergo a clinical evaluation of their affected UL as well as an evaluation of simulated pain at the affected UL. For the latter, the effect of CN-NINM on pain will be evaluated using a tonic thermal experimental pain paradigm. For this, a thermode (hot plate) will be applied to the forearm of the participants before and after a single 20-minute application of CN-NINM. On each occasion, thermal nociceptive stimuli will be induced for 2 minutes on the participants' forearm using the thermode. Although the temperature remains constant for the entire 2 minutes, the participant will be informed that the temperature may increase, decrease, or remain stable during the procedure. The participant will then, at all times, evaluate the intensity of the pain with a visual analogue scale connected to a computer (CoVAS: visual analogue scale from 0 to 100). Afterwards, the participants will take part in a 4-week training program of their affected UL (3X/week, 60-minute duration). During each training session, the CN-NINM will be applied for 20 minutes at an intensity tailored to each participant comfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study model is a pre/post intervention pilot study.
| Arm | Type | Receives |
|---|---|---|
| strength training intervention | Experimental | Procedure: Strength training interventionStrength training of the affected upper limb in chronic stroke survivors |
| Cranial nerve non-invasive neuromodulation (CN-NINM) | Experimental | Procedure: Cranial nerve non-invasive neuromodulation (CN-NINM)CN-NINM will be applied during each session of the strength training intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be ≥18 years old;
- Have had a single supratentorial stroke;
- Be in a chronic stroke phase (>6 months);
- Present motor recovery in the upper limb (UL) (Fugl-Meyer Stroke Assessment [FMA] score ≥20/66);
- Have completed any rehabilitation treatment.
Key exclusion criteria (8 listed)
- A significant spasticity at the affected upper limb (score > 3 on the modified Ashworth scale);
- A major sensory deficit at the affected upper limb (a score ≤25/34 on the Nottingham Sensory Assessment and a score <6 on the evaluation of the vibration threshold);
- A presence of hemineglect (score ≥±0. 083 on the Line Cancellation test);
- An apraxia (score >2.5 on the Alexander Test);
- The presence of a neurological disorder other than a stroke;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strength training interventionThe 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 in order to avoid tendino-muscular injuries and fatigue. The 10RM will be determined for the muscles playing a key role in the functional performance of the upper limb (the wrist extensors and the elbow and shoulder flexors). In addition, the grip muscles of the affected hand will be trained with a JAMAR® dynamometer. Training will start at 50% of 1RM and progress by 10% each week to reach 80% of 1RM by week 4. The same gradation of intensity will be applied to the grip muscles. The training will begin and end by a 5-minute warm-up and relaxation period comprising of active movements of the trained muscles. | Procedure or surgery | strength training intervention |
| Cranial nerve non-invasive neuromodulation (CN-NINM)During each strength training session, the CN-NINM will be applied, with the help of a portable stimulator comprising a network of 18 electrodes, directly on the tongue of the participants for 20 minutes. The participants will hold the CN-NINM in place by pressing their tongue upwards. The CN-NINM will generate high-frequency pulses (50 μsec to 150 Hz), and the intensity of the stimulus will be set by each participant to a comfortable level of sensation, similar to the sensation in the mouth of a soft drink. | Procedure or surgery | Cranial nerve non-invasive neuromodulation (CN-NINM) |
Primary outcome
Recruitment rate for the project
Time frame: Information will be assessed at the end of the recruitment period, at week 28
This outcome will be compiled by the total number of participants recruited, divided by the average number of months recruiting.
Refusal to participate and the reasons
Time frame: Information will be assessed throughout the project recruitment period (average of 7 months)
Participants refusal to participate will be assessed by number of participants who declined to participate in the project and the associate reasons
Dropped out rate of the project in percent and the reasons
Time frame: Information will be assessed through project completion, an average of 9 months
Dropped out rate will be collected by the number of participants who dropped out of the project divided by the total number of participants recruited X 100%. Reasons for each drop out will also be collected.
Adherence to the intervention (training program and CN-NINM) in percent
Time frame: Information will be assessed through study completion, an average of 9 months
Adherence to the intervention will be calculated by the number of training sessions completed out of the total number expected X 100%
Number of participants with CN-NINM-related adverse events as assessed by a questionnaire
Time frame: Information will be be assessed through study completion, an average of 9 months
Adverse events will be assessed with a questionnaire that will provide a number and percentage of participants who have experienced adverse events as well as allowing collecting information on symptoms that may be related to CN-NINM.
6 secondary outcomes
Change in pain intensity on the CoVAS
Time frame: The assessments will be done at the baseline and just after the 20 minutes of application of the 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 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 affected grip strength on the JAMAR dynamometer
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 manual dexterity on the Box and Block 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 participants' subjective real life functional UL performance on the Motor Activity Log
Time frame: The assessments will be done at the baseline and in the week after completion of the training program and CN-NINM.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Derived from this study: PubMed 41484860Ahiatsi M, Milot MH, Flaive A, Leonard G. Tasting pain-relief through tongue stimulation: results from a feasibility study looking into the use of cranial nerve non-invasive neuromodulation in healthy individuals and chronic poststroke patients. BMC Neurol. 2026 Jan 2;26(1):72. doi: 10.1186/s12883-025-04498-6.
- Derived from this study: PubMed 40380081Ahiatsi M, Leonard G, Riesco E, Girard MC, Milot MH. A feasibility study on the use of cranial nerve non-invasive neuromodulation to improve affected arm function in people in the chronic stage of a stroke. BMC Neurol. 2025 May 16;25(1):208. doi: 10.1186/s12883-025-04213-5.
- Individual participant dataSharing planned: No. The investigators are not planning on sharing individual data to the participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Hélène Milot, Ph.D. principal investigator
Université de Sherbrooke
Guillaume Léonard, Ph.D. principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength training intervention and Cranial nerve non-invasive neuromodulation (CN-NINM) in people with Stroke, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate for the project (time frame: Information will be assessed at the end of the recruitment period, at week 28). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05370274, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.