Non-invasive, non-pharmaceutical technologies that augment routine clinical practice for brain diseases and manage chronic symptoms have advanced rapidly over the past two decades. Among these, non-invasive brain stimulation such as transcranial direct current stimulation (tDCS) promotes neuroplasticity in injured brains, with fewer side effects and risks than invasive, implanted approaches such as deep-brain stimulation. Stimulating the brain can improve its function and help with recovery after a stroke. It has been a challenge to do this non-invasively. This is because the brain is reshaped after a stroke, and thus, it is difficult to find the right places to stimulate from the outside. In previous research, investigators found that optimal type and target of tDCS varied among subjects. The goal of this pilot trial is to test the feasibility of combining individually optimized, targeted high-definition tDCS (THD-tDCS) with rehabilitation therapy. Investigators will include 16 chronic stroke subjects with their optimal stimulation setup, obtained from their previous research. The participants will be computer-randomized into two equal-sized groups to receive either optimal THD-tDCS or sham stimulation, together with rehabilitation therapy (modified constraint-induced movement therapy, mCIMT) for five sessions over two weeks. Outcome measures will be collected at the baseline and right after the final intervention session. The primary outcome measure will be the change in the FM-UE score from baseline to immediately post the final intervention to assess the immediate effect of the intervention on upper extremity motor impairment. The secondary outcome measure will be the Wolf Motor Function Test time score to evaluate the immediate effect on functional motor performance.
Must be 18 years or older
Must have had a stroke that resulted in paresis confined to one side. The use of a wheelchair or other assisting devices are not exclusionary.
Must have substantial motor impairment of the paretic upper limb
Absence of severe wasting or contracture or significant sensory deficits in the paretic upper limb
Self-reported sensitive skin or adhesive allergy as assessed by the tDCS Safety Screening Questionnaire
Has a cardiac pacemaker, defibrillator or an implantable cardiac resynchronization therapy device
Has metal implants in the head and/or brain
Presence of muscle tone abnormalities and motor or sensory impairment in the non-paretic limb
Parallel
High-definition transcranial direct stimulation: sham
DeviceHigh-definition transcranial direct stimulation with zero stimulation intensity (placebo)
High-definition transcranial direct stimulation: optimal
DeviceHigh-definition transcranial direct stimulation with individualized, optimal parameters.
Modified constraint-induced movement therapy
BehavioralModified Constraint-Induced Movement Therapy (mCIMT) is an evidence-based neurorehabilitation approach that improves upper limb function after stroke or brain injury by restricting the unaffected limb while intensively training the affected limb.
Change in the Fugl-Meyer Upper Extremity score from baseline
Fugl-Meyer Upper Extremity (FM-UE) is a measure of motor impairment (0 to 66 points, with higher points indicating less impairment). FM-UE scale consists of a 33-item assessment which provides a global assessment of upper extremity motor impairment. A rater provides an ordinal rating (2=near normal ability/response, 1=partial ability, 0=unable to perform/no response) for each item.
Change in the Wolf Motor Function Test Time Score From Baseline
Wolf Motor Function (WMFT) Test is a measure of functional motor activity that quantifies upper extremity motor ability through timed and functional tasks. The WMFT Time Score the median of 15 timed arm movements and hand dexterity tasks, each to be completed up to 120s. If a task could not be completed in 120s, a score of 121s was assigned. Higher score indicates a worse motor function.
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Carle Foundation Hospital
Lead sponsor
American Heart Association
Collaborator
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