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Brain Stimulation and Tailored Interventions to Promote Recovery in Stroke Survivors

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ClinicalTrials.gov Identifier: NCT02915185
Recruitment Status : Recruiting
First Posted : September 26, 2016
Last Update Posted : October 17, 2018
Sponsor:
Collaborators:
Brain Canada
Fonds de recherche du Québec
Fondation Vitae
Centre de recherche interdisciplinaire en réadaptation du Montréal métropolitain
Jewish Rehabilitation Hospital
Information provided by (Responsible Party):
Marie-Hélène Milot, Université de Sherbrooke

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.

Condition or disease Intervention/treatment Phase
Stroke Procedure: strength training intervention Device: tDCS Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combining Neurostimulation Technique With Tailored Interventions for the Affected Upper Extremity: Can it Promote Better Recovery in Stroke Survivors?
Actual Study Start Date : April 28, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Arm Intervention/treatment
Experimental: strength training intervention
Strength training of the affected upper limb in chronic stroke survivors
Procedure: strength training intervention
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
Device: tDCS
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 Measures :
  1. Change in Fugl-Meyer Stroke Assessment Scale [ Time Frame: baseline and in the week after completion of the training program ]
  2. 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 Measures :
  1. Change in grip strength [ Time Frame: baseline and in the week after completion of the training program ]
  2. Change in Box and Block test [ Time Frame: baseline and in the week after completion of the training program ]
    manual dexterity

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. have had solely one supratentorial stroke
  2. be in a chronic stroke phase (>6 months)

Exclusion Criteria:

  1. a significant spasticity at the affected upper limb (score > 3 on the modified Ashworth scale);
  2. a significant pain intensity at the affected upper limb (≥ 4/10 on the Visual Analog Pain Scale);
  3. a major sensory deficit (a score ≤ 25/34 on the Nottingham Sensory Assessment);
  4. a presence of hemineglect (> 70% of unshaded lines on the same side as the motor deficit on the Line Cancellation Test);
  5. an apraxia (score >2.5 on the Alexander Test);
  6. the presence of a neurological disorder other than a stroke;
  7. concomitant orthopaedic problems at the affected upper limb and
  8. any contraindication to TMS and/or tDCS.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02915185


Contacts
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Contact: Marie-Helene Milot, PhD 819-780-2220 ext 45277 marie-helene.milot@usherbrooke.ca
Contact: Hélène Corriveau, PhD 819-780-2220 ext 45427 helene.corriveau@usherbrooke.ca

Locations
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Canada, Ontario
Bruyère Research Institute Recruiting
Ottawa, Ontario, Canada, K1N 5C8
Contact: Trish Whelan    613-562-6262 ext 2902    TWhelan@bruyere.org   
Contact: Alex Cornett    613-562-6262 ext 1434    acornett@bruyere.org   
Principal Investigator: François Tremblay, PhD         
Canada, Quebec
CRIR/Feil/Oberfeld Research Center; Centre intégré de santé et de services sociaux de Laval; Jewish Rehabilitation Hospital Recruiting
Laval, Quebec, Canada, H7V 1R2
Contact: Marie-Helene Boudrias, PhD    514-398-5457    mh.boudrias@mcgill.ca   
Contact: Stephania Palimeris, BsC       stephania.palimeris@mail.mcgill.ca   
Principal Investigator: Marie-Helene Boudrias, PhD         
Centre de recherche sur le vieillissement Recruiting
Sherbrooke, Quebec, Canada, J1H4C4
Contact: Marie-Helene Milot, PhD    819-780-2220 ext 45277    marie-helene.milot@usherbrooke.ca   
Contact: Hélène Corriveau, PhD    819-780-2220 ext 45427    helene.corriveau@usherbrooke.ca   
Principal Investigator: Marie-Helene Milot, PhD         
Sub-Investigator: Hélène Corriveau, PhD         
Sponsors and Collaborators
Université de Sherbrooke
Brain Canada
Fonds de recherche du Québec
Fondation Vitae
Centre de recherche interdisciplinaire en réadaptation du Montréal métropolitain
Jewish Rehabilitation Hospital
Investigators
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Principal Investigator: Marie-Helene Milot, PhD Université de Sherbrooke

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marie-Hélène Milot, Researcher, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT02915185     History of Changes
Other Study ID Numbers: MP-22-2016-630
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The investigators are not planning on sharing individual data to the participants

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marie-Hélène Milot, Université de Sherbrooke:
exercise
rehabilitation
recovery of function
transcranial magnetic stimulation
transcranial direct-current stimulation
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases