An interventional study of tDCS and sham tDCS in Stroke, Arm and Paresis, sponsored by McGill University. Completed at 1 site in Canada. Open to participants aged 25 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-01-03.
Sponsored by McGill University · Not applicable, Interventional, and Treatment
Many people who have had a stroke have problems recovering the use of their affected arm and these problems may persist for a long time. The investigators' research will test new ways to boost recovery by using non-painful brain stimulation together with training of arm movements using basic science principles. The training program will be done using the latest technology in rehabilitation such as virtual reality and robotics. The investigators will compare three groups of patients who have had a stroke. Each group will receive different combinations of brain stimulation and arm training. Another aspect of this proposal is that the investigators will do the same training programs in three different countries - Canada, Israel and India. In this way, the investigators will combine knowledge and skills to create training programs that can be applied anywhere in the world and that are not necessarily limited to high-income countries. Also, by combining expertise, the investigators will help to build the capacity to do research in India, a middle-income country that has great potential to contribute new knowledge to rehabilitation medicine.
Training approaches based on established principles of motor learning and neural plasticity and non-invasive brain stimulation such as repetitive Transcranial Magnetic Stimulation and transcranial Direct Current Stimulation (tDCS) show promise in modulating brain activity in order to enhance upper limb (UL) motor recovery. However, the potential for recovery may still not be attained if training programs do not specifically focus on remediating motor impairment as defined by motor control science. This project is driven by a major theory of motor control (Threshold Control Theory) suggesting that rather than directly specifying motor commands to muscles, descending systems regulate spatial thresholds (STs) of reflexes to generate and control voluntary movement within specific areas of joint space. In patients with stroke, ST control is diminished leading to the appearance of muscle spasticity, weakness and abnormal muscle activation patterns during voluntary movement within well-defined spatial (angular) zones. The investigators hypothesize that recovery of voluntary motor control is tightly linked to the recovery of threshold control. The investigators propose a training program that incorporates personalized tDCS to balance cortical hypo/hyperexcitability as well as personalized movement arm reaching training based on the identification of disorders in ST.
Overall objectives of the proposal are:
Sixty patients with sub-acute (3 wks-6 mos) stroke will be recruited in this multi-site international trial taking place in Canada, Israel and India. Participants will have spasticity in the elbow flexors and/or extensors, with some active elbow control. Each site will recruit and randomize patients into one of 3 treatment groups. Group 1 will receive tDCS and practice personalized arm motor training. Group 2 will also receive tDCS with non-specific practice. Group 3 will receive Sham-tDCS and personalized practice. Training will consist of the application of tDCS in the first 30 minutes of a 50-minute arm reaching practice session,, 5 days per week for 2 weeks. Primary outcome measures (Pre, Post, Follow-up) are elbow flexor and extensor STs and related spasticity/active control zones. Secondary measures are clinical measures of UL motor activity. By accounting for the spatial structure of motor deficits, our research will benefit both researchers and clinicians by advancing our understanding of the mechanisms underlying unimpaired/impaired motor control and recovery.
519 studies on the registry are indexed under Paresis; 111 are open to participants now.
This study's enrollment of 50 is above the median of 36 across 448 interventional studies indexed under Paresis.
Browse Paresis studies →McGill University is the lead sponsor of 244 studies on the registry; 49 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Transcranial direct current stimulation and personalized arm motor training limited to active control zones, 1 hour per day, 5 days per week for 2 weeks
Device: tDCS · Behavioral: personalized practice
Transcranial direct current stimulation and non-personalized arm motor training spanning both active control and spasticity zones, 1 hour per day, 5 days per week for 2 weeks
Device: tDCS · Behavioral: non-personalized practice
Sham transcranial direct current stimulation and personalized arm motor training limited to active control zones, 1 hour per day, 5 days per week for 2 weeks
Device: sham tDCS · Behavioral: personalized practice
Application of 1.5 mA tDCS for 30 minutes
Application of sham tDCS for 30 minutes
arm exercise consisting of whole arm movement within a restricted elbow range of motion
arm exercise consisting of unrestricted whole arm movement
Change in active control zone of the elbow
Post-test and Follow-up test; measured using motion analysis system.
Time frame: 2 weeks and 1 month
Change in Fugl-Meyer Assessment of arm impairment score
Post-test and Follow-up test; Score of 66 points indicates normal functioning.
Time frame: 2 weeks and 1 month
Change in spasticity score
Post-test and Follow-up test; 6 point ordinal scale
Time frame: 2 weeks and 1 month
Change in streamlined Wolf Motor Function Test score
Post-test and Follow-up test;30 point ordinal scale
Time frame: 2 weeks and 1 month
Change in active range of elbow extension
Post-test and Follow-up test; measured with a hand-held goniometer
Time frame: 2 weeks and 1 month
Change in straightness of elbow trajectory during a reach to grasp task
Post-test and Follow-up test; measured using a motion analysis system
Time frame: 2 weeks and 1 month
Change in speed of endpoint movement during a reach to grasp task
Post-test and Follow-up test; measured using a motion analysis system
Time frame: 2 weeks and 1 month
Change in smoothness of endpoint trajectory during a reach to grasp task
Post-test and Follow-up test; measured using a motion analysis system
Time frame: 2 weeks and 1 month
Plan to share: No
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