Brain Stimulation and Tailored Interventions to Promote Recovery in Stroke Survivors
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
strength training intervention
tDCS
Sponsored by

About this trial
This is an interventional treatment trial for Stroke focused on measuring exercise, rehabilitation, recovery of function, transcranial magnetic stimulation, transcranial direct-current stimulation
Eligibility Criteria
Inclusion Criteria:
- have had solely one supratentorial stroke
- be in a chronic stroke phase (>6 months)
Exclusion Criteria:
- 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.
Sites / Locations
- Bruyère Research Institute
- CRIR/Feil/Oberfeld Research Center; Centre intégré de santé et de services sociaux de Laval; Jewish Rehabilitation Hospital
- Centre de recherche sur le vieillissement
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
strength training intervention
direct-current brain stimulation (tDCS)
Arm Description
Strength training of the affected upper limb in chronic stroke survivors
tDCS real of sham will be applied during each session of the strength training intervention
Outcomes
Primary Outcome Measures
Change in Fugl-Meyer Stroke Assessment Scale
Change in peak-to-peak motor evoked potential amplitude and motor threshold elicited by transcranial magnetic stimulation
Secondary Outcome Measures
Change in grip strength
Change in Box and Block test
manual dexterity
Change in Motor Activity Log
participants' self-reported affected upper limb's level and quality of use in everyday activities
Full Information
NCT ID
NCT02915185
First Posted
September 21, 2016
Last Updated
April 26, 2022
Sponsor
Université de Sherbrooke
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
1. Study Identification
Unique Protocol Identification Number
NCT02915185
Brief Title
Brain Stimulation and Tailored Interventions to Promote Recovery in Stroke Survivors
Official Title
Combining Neurostimulation Technique With Tailored Interventions for the Affected Upper Extremity: Can it Promote Better Recovery in Stroke Survivors?
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 28, 2017 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
January 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke
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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
exercise, rehabilitation, recovery of function, transcranial magnetic stimulation, transcranial direct-current stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
strength training intervention
Arm Type
Experimental
Arm Description
Strength training of the affected upper limb in chronic stroke survivors
Arm Title
direct-current brain stimulation (tDCS)
Arm Type
Experimental
Arm Description
tDCS real of sham will be applied during each session of the strength training intervention
Intervention Type
Procedure
Intervention Name(s)
strength training intervention
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Fugl-Meyer Stroke Assessment Scale
Time Frame
baseline and in the week after completion of the training program
Title
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
Secondary Outcome Measure Information:
Title
Change in grip strength
Time Frame
baseline and in the week after completion of the training program
Title
Change in Box and Block test
Description
manual dexterity
Time Frame
baseline and in the week after completion of the training program
Title
Change in Motor Activity Log
Description
participants' self-reported affected upper limb's level and quality of use in everyday activities
Time Frame
baseline and in the week after completion of the training program
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
have had solely one supratentorial stroke
be in a chronic stroke phase (>6 months)
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Helene Milot, PhD
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bruyère Research Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1N 5C8
Country
Canada
Facility Name
CRIR/Feil/Oberfeld Research Center; Centre intégré de santé et de services sociaux de Laval; Jewish Rehabilitation Hospital
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7V 1R2
Country
Canada
Facility Name
Centre de recherche sur le vieillissement
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H4C4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The investigators are not planning on sharing individual data to the participants
Citations:
PubMed Identifier
36189037
Citation
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.
Results Reference
derived
PubMed Identifier
31139420
Citation
Milot 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.
Results Reference
derived
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Brain Stimulation and Tailored Interventions to Promote Recovery in Stroke Survivors
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