StrokeNCT02915185
Brain Stimulation and Tailored Interventions to Promote Recovery in Stroke Survivors
A study testing strength training intervention and tDCS in people with Stroke, run by Université de Sherbrooke at 3 sites in Canada.
Trial summary
A substantial proportion of individuals are left with poor residual functioning of the affected arm after a stroke. This has a tremendous impact on the quality of life and the ability for stroke survivors to live independently. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- strength training intervention and tDCS
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesCanada
- Study dates
- 28 Apr 2017to 31 Jan 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have had solely one supratentorial stroke
- be in a chronic stroke phase (>6 months)
Who cannot join
- a significant spasticity at the affected upper limb (score > 3 on the modified Ashworth scale);
- a significant pain intensity at the affected upper limb (≥ 4/10 on the Visual Analog Pain Scale);
- a major sensory deficit (a score ≤ 25/34 on the Nottingham Sensory Assessment);
- a presence of hemineglect (> 70% of unshaded lines on the same side as the motor deficit 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 problems at the affected upper limb and
- any contraindication to TMS and/or tDCS.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
CRIR/Feil/Oberfeld Research Center; Centre intégré de santé et de services sociaux de Laval; Jewish Rehabilitation Hospital
Laval, Quebec, H7V 1R2
Bruyère Research Institute
Ottawa, Ontario, K1N 5C8
Centre de recherche sur le vieillissement
Sherbrooke, Quebec, J1H4C4
About this study
Official title: Combining Neurostimulation Technique With Tailored Interventions for the Affected Upper Extremity: Can it Promote Better Recovery in Stroke Survivors?
A substantial proportion of individuals are left with poor residual functioning of the affected arm after a stroke. This has a tremendous impact on the quality of life and the ability for stroke survivors to live independently. While exercise is considered essential to any rehabilitation program, its benefits are generally far from optimal because of the lack of proper dosing in terms of intensity. One way to tackle this problem is to develop better tools that could predict an individual's potential and then adjust the intensity of exercise accordingly. One such predicting tool exists and consists of using non-invasive brain stimulation such as transcranial magnetic stimulation (TMS), to assess the integrity of descending motor pathways originating from the brain. TMS consists of applying a magnetic wand near the scalp to stimulate brain cells without inducing pain or discomfort. One goal of the current proposal is to use TMS to test the integrity of the motor pathway in chronic stroke survivors. The level of responses to TMS will be used to classify participants in terms of potential for recovery and then, to determine the optimal level of exercise. The study will also examine the effect of another non-invasive brain stimulation technique called transcranial Direct-Current Stimulation-tDCS to determine whether it can enhance the response to strength training exercise in the affected arm. Half of the participants will be trained with the tDCS on, while the other half will be trained with the stimulator off. The training program will last 4 weeks; 3X/week. Both clinical and neurophysiological measures will be performed to determine the impact of the strength training intervention on participants. Overall, the proposed project is expected to have a positive and significant impact on stroke survivors' quality of life.
Read the detailed description
The functional impact of impairment to UL following a stroke is critical given the close association between residual strength at the affected UL and performance in activity post-stroke. Exercise is a key element to recovery, even in chronic stroke survivors. However, the response to exercise is quite variable between individuals, reflecting the fact exercise intervention is often based on stroke survivors' clinical score as opposed to their potential for recovery. Accordingly, clients with comparable clinical presentations will often receive a similar intervention, even though they may exhibit very different potential for recovery. Hence, using a suitable prognostic tool of post-stroke recovery to individualize interventions based on individual potential for recovery is essential. One such tool is non-invasive transcranial magnetic stimulation (TMS). TMS elicits motor evoked potentials (MEP), which in turn provide a measure to conveniently assess the integrity of the corticospinal pathway. MEP is currently recognized as a good prognosis for post-stroke potential recovery. Another factor that can improve response to exercise is by modulating the excitability of sensorimotor circuits in the brain by the use of transcranial Direct-Current Stimulation (tDCS). Studies have shown that priming the motor cortex with tDCS before or during an intervention can promote motor recovery in stroke patients.
Goals: 1) To assess if an MEP amplitude stratification, used to guide exercise prescription, can optimize UL function in chronic stroke survivors; 2) To evaluate whether adding tDCS to a more individualized exercise intervention can further improve UL function.
Methods: Participants will be stratified based on their MEPs amplitudes at the affected hand. Within each stratum, participants will be further randomized into two tDCS groups: tDCS real and tDCS sham. The strength training program will target the affected upper limb and will last 4 weeks (3 times/week).The tDCS will be applied to an anodal montage during each training session (12 sessions; 2 mA) for 20 minutes (tDCS real group) or 30 seconds (tDCS sham group).
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 times/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, which are 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. Participants' maximal grip force will be determined and used to dose the training of the hand muscles and its progression. The training will begin and end by a 5-minute warm-up and relaxation period comprising of active movements of the trained muscles.
tDCSDevice
An anodal montage over the ipsilesional hemisphere will be used where the anode will be placed over the ipsilesional M1 area whereas the cathode will be placed on the contralateral supra-orbital region.For the tDCS real group, a direct current will be generated by a tDCS stimulator and gradually increased in a ramp-like fashion over the first 8 seconds until a maximum intensity of 2 mA is achieved. The tDCS will be applied for 20 minutes during each training session for a total of 12 sessions. For the group receiving sham tDCS, the protocol will be similar to the tDCS real group although the stimulation will be applied for the first 30 seconds only; a duration long enough to induce similar perceived sensation as real tDCS (tingling), to keep participants' blind to the tDCS type.
| 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 |
| direct-current brain stimulation (tDCS) | Experimental | tDCS real of sham will be applied during each session of the strength training intervention Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fugl-Meyer Stroke Assessment Scale
Measured: baseline and in the week after completion of the training program
Change in peak-to-peak motor evoked potential amplitude and motor threshold elicited by transcranial magnetic stimulation
Measured: baseline and in the week after completion of the training program
Secondary outcomes (3)
Change in grip strength
Measured: baseline and in the week after completion of the training program
Change in Box and Block test
manual dexterity
Measured: baseline and in the week after completion of the training program
Change in Motor Activity Log
participants' self-reported affected upper limb's level and quality of use in everyday activities
Measured: baseline and in the week after completion of the training program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study start28 Apr 2017
- Primary completion28 Feb 2020
- Study completion31 Jan 2022
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Brain Canada, Fonds de la Recherche en Santé du Québec, Fondation Vitae, Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale, Jewish Rehabilitation Hospital
- Responsible party
- Principal investigator, Marie-Hélène Milot, Université de Sherbrooke
- Investigators
- Marie-Helene Milot, PhD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02915185
- Sponsor's protocol ID
- MP-22-2016-630
- Status last verified
- Apr 2022
- First submitted
- 21 Sep 2016
- Last updated
- 27 Apr 2022
- 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
Palimeris S, Ansari Y, Remaud A, Tremblay F, Corriveau H, Boudrias MH, Milot MH. Effect of a tailored upper extremity strength training intervention combined with direct current stimulation in chronic stroke survivors: A Randomized Controlled Trial. Front Rehabil Sci. 2022 Aug 3;3:978257. doi: 10.3389/fresc.2022.978257. eCollection 2022.
PubMed 36189037Milot MH, Palimeris S, Corriveau H, Tremblay F, Boudrias MH. Effects of a tailored strength training program of the upper limb combined with transcranial direct current stimulation (tDCS) in chronic stroke patients: study protocol for a randomised, double-blind, controlled trial. BMC Sports Sci Med Rehabil. 2019 May 24;11:8. doi: 10.1186/s13102-019-0120-1. eCollection 2019.
PubMed 31139420
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Neurostimulation Technique With Tailored Interventions for the Affected Upper Extremity: Can it Promote Better Recovery in Stroke Survivors?
- ClinicalTrials.gov ID
- NCT02915185
- Acronym / sponsor ID
- MP-22-2016-630
- Conditions
- Stroke
- Keywords
- exercise, rehabilitation, recovery of function, transcranial magnetic stimulation, transcranial direct-current stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Brain Canada, Fonds de la Recherche en Santé du Québec, Fondation Vitae, Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale, Jewish Rehabilitation Hospital
- Study start
- 28 Apr 2017 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 26 Sep 2016 (estimated)
- 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.
A substantial proportion of individuals are left with poor residual functioning of the affected arm after a stroke. This has a tremendous impact on the quality of life and the ability for stroke survivors to live independently. While exercise is considered essential to any rehabilitation program, its benefits are generally far from optimal because of the lack of proper dosing in terms of intensity. One way to tackle this problem is to develop better tools that could predict an individual's potential and then adjust the intensity of exercise accordingly. One such predicting tool exists and consists of using non-invasive brain stimulation such as transcranial magnetic stimulation (TMS), to assess the integrity of descending motor pathways originating from the brain. TMS consists of applying a magnetic wand near the scalp to stimulate brain cells without inducing pain or discomfort. One goal of the current proposal is to use TMS to test the integrity of the motor pathway in chronic stroke survivors. The level of responses to TMS will be used to classify participants in terms of potential for recovery and then, to determine the optimal level of exercise. The study will also examine the effect of another non-invasive brain stimulation technique called transcranial Direct-Current Stimulation-tDCS to determine whether it can enhance the response to strength training exercise in the affected arm. Half of the participants will be trained with the tDCS on, while the other half will be trained with the stimulator off. The training program will last 4 weeks; 3X/week. Both clinical and neurophysiological measures will be performed to determine the impact of the strength training intervention on participants. Overall, the proposed project is expected to have a positive and significant impact on stroke survivors' quality of life.
Detailed description
The functional impact of impairment to UL following a stroke is critical given the close association between residual strength at the affected UL and performance in activity post-stroke. Exercise is a key element to recovery, even in chronic stroke survivors. However, the response to exercise is quite variable between individuals, reflecting the fact exercise intervention is often based on stroke survivors' clinical score as opposed to their potential for recovery. Accordingly, clients with comparable clinical presentations will often receive a similar intervention, even though they may exhibit very different potential for recovery. Hence, using a suitable prognostic tool of post-stroke recovery to individualize interventions based on individual potential for recovery is essential. One such tool is non-invasive transcranial magnetic stimulation (TMS). TMS elicits motor evoked potentials (MEP), which in turn provide a measure to conveniently assess the integrity of the corticospinal pathway. MEP is currently recognized as a good prognosis for post-stroke potential recovery. Another factor that can improve response to exercise is by modulating the excitability of sensorimotor circuits in the brain by the use of transcranial Direct-Current Stimulation (tDCS). Studies have shown that priming the motor cortex with tDCS before or during an intervention can promote motor recovery in stroke patients.
Goals: 1) To assess if an MEP amplitude stratification, used to guide exercise prescription, can optimize UL function in chronic stroke survivors; 2) To evaluate whether adding tDCS to a more individualized exercise intervention can further improve UL function.
Methods: Participants will be stratified based on their MEPs amplitudes at the affected hand. Within each stratum, participants will be further randomized into two tDCS groups: tDCS real and tDCS sham. The strength training program will target the affected upper limb and will last 4 weeks (3 times/week).The tDCS will be applied to an anodal montage during each training session (12 sessions; 2 mA) for 20 minutes (tDCS real group) or 30 seconds (tDCS sham group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| strength training intervention | Experimental | Procedure: strength training interventionStrength training of the affected upper limb in chronic stroke survivors |
| direct-current brain stimulation (tDCS) | Experimental | Device: tDCStDCS real of sham will be applied during each session of the strength training intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- have had solely one supratentorial stroke
- be in a chronic stroke phase (>6 months)
Key exclusion criteria (8 listed)
- a significant spasticity at the affected upper limb (score > 3 on the modified Ashworth scale);
- a significant pain intensity at the affected upper limb (≥ 4/10 on the Visual Analog Pain Scale);
- a major sensory deficit (a score ≤ 25/34 on the Nottingham Sensory Assessment);
- a presence of hemineglect (> 70% of unshaded lines on the same side as the motor deficit on the Line Cancellation Test);
- an apraxia (score >2.5 on the Alexander Test);
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 times/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, which are 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. Participants' maximal grip force will be determined and used to dose the training of the hand muscles and its progression. 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 |
| tDCSAn anodal montage over the ipsilesional hemisphere will be used where the anode will be placed over the ipsilesional M1 area whereas the cathode will be placed on the contralateral supra-orbital region.For the tDCS real group, a direct current will be generated by a tDCS stimulator and gradually increased in a ramp-like fashion over the first 8 seconds until a maximum intensity of 2 mA is achieved. The tDCS will be applied for 20 minutes during each training session for a total of 12 sessions. For the group receiving sham tDCS, the protocol will be similar to the tDCS real group although the stimulation will be applied for the first 30 seconds only; a duration long enough to induce similar perceived sensation as real tDCS (tingling), to keep participants' blind to the tDCS type. | Device | direct-current brain stimulation (tDCS) |
Primary outcome
Change in Fugl-Meyer Stroke Assessment Scale
Time frame: baseline and in the week after completion of the training program
Change in peak-to-peak motor evoked potential amplitude and motor threshold elicited by transcranial magnetic stimulation
Time frame: baseline and in the week after completion of the training program
3 secondary outcomes
Change in grip strength
Time frame: baseline and in the week after completion of the training program
Change in Box and Block test
Time frame: baseline and in the week after completion of the training program
Change in Motor Activity Log
Time frame: baseline and in the week after completion of the training program
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 27 Apr 2022.
- Derived from this study: PubMed 36189037Palimeris S, Ansari Y, Remaud A, Tremblay F, Corriveau H, Boudrias MH, Milot MH. Effect of a tailored upper extremity strength training intervention combined with direct current stimulation in chronic stroke survivors: A Randomized Controlled Trial. Front Rehabil Sci. 2022 Aug 3;3:978257. doi: 10.3389/fresc.2022.978257. eCollection 2022.
- Derived from this study: PubMed 31139420Milot MH, Palimeris S, Corriveau H, Tremblay F, Boudrias MH. Effects of a tailored strength training program of the upper limb combined with transcranial direct current stimulation (tDCS) in chronic stroke patients: study protocol for a randomised, double-blind, controlled trial. BMC Sports Sci Med Rehabil. 2019 May 24;11:8. doi: 10.1186/s13102-019-0120-1. eCollection 2019.
- Individual participant dataSharing planned: No. The investigators are not planning on sharing individual data to the participants
Related trials for Stroke
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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-Helene Milot, PhD principal investigator
Université de Sherbrooke
3 sites 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 tDCS in people with Stroke, run by Université de Sherbrooke at 3 sites 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 2 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 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Change in Fugl-Meyer Stroke Assessment Scale (time frame: baseline and in the week after completion of the training program). The study lists 2 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 NCT02915185, 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 27 Apr 2022.