- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02915185
Brain Stimulation and Tailored Interventions to Promote Recovery in Stroke Survivors
Combining Neurostimulation Technique With Tailored Interventions for the Affected Upper Extremity: Can it Promote Better Recovery in Stroke Survivors?
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1N 5C8
- Bruyère Research Institute
-
-
Quebec
-
Laval, Quebec, Canada, H7V 1R2
- CRIR/Feil/Oberfeld Research Center; Centre intégré de santé et de services sociaux de Laval; Jewish Rehabilitation Hospital
-
Sherbrooke, Quebec, Canada, J1H4C4
- Centre de recherche sur le vieillissement
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: strength training intervention
Strength training of the affected upper limb in chronic stroke survivors
|
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.
|
Experimental: direct-current brain stimulation (tDCS)
tDCS real of sham will be applied during each session of the strength training intervention
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Fugl-Meyer Stroke Assessment Scale
Time Frame: baseline and in the week after completion of the training program
|
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
|
baseline and in the week after completion of the training program
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in grip strength
Time Frame: baseline and in the week after completion of the training program
|
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
|
manual dexterity
|
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
|
participants' self-reported affected upper limb's level and quality of use in everyday activities
|
baseline and in the week after completion of the training program
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Marie-Helene Milot, PhD, Universite de Sherbrooke
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MP-22-2016-630
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.RecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, CryptogenicSingapore, Philippines
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Vanderbilt University Medical CenterPatient-Centered Outcomes Research Institute; University of Alabama at BirminghamEnrolling by invitationStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Engagement, Patient | Stroke HemorrhagicUnited States
-
University of MinnesotaAmerican Occupational Therapy FoundationRecruitingStroke | Stroke Sequelae | Stroke Hemorrhagic | Stroke IschemicUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
-
University of CincinnatiMedical University of South Carolina; University of California, Los Angeles; University...RecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke HemorrhagicUnited States
-
Turkish Stroke Research and Clinical Trials NetworkElectroCore INC; Turkish Neurological SocietyCompletedStroke | Stroke, Ischemic | Stroke, Acute | Stroke, HemorrhagicTurkey
-
University of LiegeCompletedStroke, Acute | Stroke Hemorrhagic | Stroke, ComplicationBelgium
Clinical Trials on strength training intervention
-
University of GiessenHannover Medical SchoolUnknownType 2 DiabetesGermany
-
University of South-Eastern NorwayThe Norwegian Olympic Sports Center (Olympiatoppen)Completed
-
University of MinnesotaRecruitingPhysical InactivityUnited States
-
Aalborg University HospitalCompleted
-
Zeinab HusseinCairo UniversityCompleted
-
Norwegian University of Science and TechnologySt. Olavs HospitalCompletedCoronary Artery Disease | Heart FailureNorway
-
University of FloridaCompleted
-
University of PittsburghCompleted
-
VA Office of Research and DevelopmentCompletedHeart FailureUnited States
-
University of AarhusUnknownOsteoarthritis, KneeDenmark