NCT02915185

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

April 28, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

2.8 years

First QC Date

September 21, 2016

Last Update Submit

April 26, 2022

Conditions

Stroke

Keywords

exerciserehabilitationrecovery of functiontranscranial magnetic stimulationtranscranial direct-current stimulation

Outcome Measures

Primary Outcomes (2)

  • Change in Fugl-Meyer Stroke Assessment Scale

    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

    baseline and in the week after completion of the training program

Secondary Outcomes (3)

  • Change in grip strength

    baseline and in the week after completion of the training program

  • Change in Box and Block test

    baseline and in the week after completion of the training program

  • Change in Motor Activity Log

    baseline and in the week after completion of the training program

Study Arms (2)

strength training intervention

EXPERIMENTAL

Strength training of the affected upper limb in chronic stroke survivors

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

Device: tDCS

Interventions

strength training interventionPROCEDURE

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.

strength training intervention
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.

direct-current brain stimulation (tDCS)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • have had solely one supratentorial stroke
  • be in a chronic stroke phase (\>6 months)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Bruyère Research Institute

Ottawa, Ontario, K1N 5C8, Canada

Location

CRIR/Feil/Oberfeld Research Center; Centre intégré de santé et de services sociaux de Laval; Jewish Rehabilitation Hospital

Laval, Quebec, H7V 1R2, Canada

Location

Centre de recherche sur le vieillissement

Sherbrooke, Quebec, J1H4C4, Canada

Location

Related Publications (2)

  • 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.

    PMID: 36189037DERIVED

  • 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.

    PMID: 31139420DERIVED

MeSH Terms

Conditions

StrokeMotor Activity

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Marie-Helene Milot, PhD

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

September 21, 2016

First Posted

September 26, 2016

Study Start

April 28, 2017

Primary Completion

February 28, 2020

Study Completion

January 31, 2022

Last Updated

April 27, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

The investigators are not planning on sharing individual data to the participants

Locations

CA(3)