A Phase 1 interventional study of tDCS and Sham tDCS in Stroke, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-28.
Sponsored by Medical University of South Carolina · Phase 1, Interventional, and Treatment
This project will evaluate two different methods of normalizing the center of mass acceleration (COMa) in individuals post-stroke, specifically focusing on rates and pattern of recovery to analyze walking-specific adaptations as precursors to motor learning. In addition, the proposed project seeks to establish the optimal configuration of electrodes to activate neural circuits involved in post-stroke locomotion. Once the better method of training COMa and optimal parameters of electrode placement for tDCS are identified, the investigators will evaluate the effects of tDCS on locomotor adaptations during single sessions and over a five-day training period.
The project seeks to establish the optimal configuration of electrodes to change the excitability of neural circuits involved in post-stroke locomotion, identify effective strategies for training a specific locomotor adaptation, and improve adaptations via adjunctive non-invasive brain stimulation. Tools to improve neural excitability may increase potential for locomotor skill learning, thereby improving rehabilitation outcomes. Non-invasive brain stimulation with transcranial direct current stimulation (tDCS) has recently emerged as a simple to administer, low-cost, and low-risk option for stimulating brain tissue. Cortical excitability is increased after application and preliminary results imply a relationship to increases in motor activity in those post-stroke. However, inhibition of the contralesional hemisphere is also shown to improve paretic motor output through inhibition of excessive maladaptive strategies, and combining the two electrode configurations may provide additional benefit for locomotor tasks requiring interlimb coordination. Furthermore, the effects of tDCS on walking function in conjunction with physical intervention strategies aimed at improving locomotor ability post-stroke are yet unstudied.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 29 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.
Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.
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Inclusion Criteria: Chronic Stroke
Exclusion Criteria: Acute Stroke
Walking on an inclined treadmill, thus manipulating the permissive environment to elicit COMa adaptation, while receiving either tDCS or sham tDCS.
Device: tDCS · Device: Sham tDCS
Walking on a declined treadmill, thus manipulating the permissive environment to elicit COMa adaptation, while receiving either tDCS or sham tDCS.
Device: tDCS · Device: Sham tDCS
Constant non-invasive, low intensity, direct electrical current utilized to stimulate specific areas of the brain. Evaluating immediate effects of anodal/cathodal stimulation during 20 minutes of treadmill walking.
Per published protocols, tDCS will be administered for 30 secs allowing for sensory adaptation to occur and then turned off, so that the remaining sham "stimulation" will include zero current. Evaluating immediate effects during 20 minutes walking on a treadmill.
Center of Mass Acceleration Peak
Peak full body center of mass acceleration during gait, expressed as m/sec\^2, captured during 30 seconds of treadmill walking at a steady-state, self-selected walking speed.
Time frame: Pre (same as initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.
Center of Mass Acceleration Impulse
Positive integral of the full body center of mass acceleration during the gait cycle, expressed as an average over all strides captured during 30 seconds of data collection at a steady-state, self-selected walking speed (m/sec).
Time frame: Pre (directly prior to initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.
Self-selected walking speed
Walking speed overground for 10 meters, average of 3 timed trials, expressed as m/sec.
Time frame: Pre (directly prior to initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.
Paretic step ratio
Percentage of the total stride completed by paretic step. This is a unit-less measure. Each stride is initiated by foot strike of the paretic leg, and the data are expressed as an average over all strides captured during 30 seconds of data collection at a steady-state, self-selected walking speed.
Time frame: Pre (directly prior to initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.
Plan to share: Yes
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Medical University of South Carolina