Optimizing Transcranial Direct Current Stimulation for Motor Recovery From Severe Post-stroke Hemiparesis
- Conditions
- StrokeHemiparesis
- Interventions
- Device: transcranial direct current stimulationBehavioral: intensive upper extremity motor training
- Registration Number
- NCT04574973
- Lead Sponsor
- University of Kentucky
- Brief Summary
Individuals who experienced a stroke over one year ago will be randomly assigned to receive 1 of 4 different conditions of brain stimulation. All individuals will receive therapy of the hand and arm following the stimulation. This study will try to determine which brain stimulation condition leads to the greatest improvement in hand and arm function.
- Detailed Description
This study will look at the effects of a painless, non-invasive form of brain stimulation, called transcranial direct current stimulation, or tDCS. tDCS is thought to increase the brain's ability to change. Participants will be assigned to one of four groups by chance. Three groups will receive tDCS at a level expected to increase the brain's ability to change, and will vary by the areas of the brain that are stimulated. The fourth group will receive tDCS at a level not thought to affect the brain's ability to change. All participants will receive intensive therapy of their impaired arm and hand, focusing on exercises that will improve their ability to function in daily life.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
- 12 or more months post-stroke
- Inability to extend the affected metacarpophalangeal joints at least 10 degrees and the wrist 20 degrees
- Addition or change in dosage of drugs known to exert detrimental effects on motor recovery within 3 month of enrollment
- Untreated depression
- History of multiple strokes
Exclusion criteria for TMS evaluations:
- History of head injury with loss of consciousness
- History of severe alcohol or drug abuse, or psychiatric illness
- Positive pregnancy test or being of childbearing age and not using appropriate contraception
- Presence of ferromagnetic material in the cranium except in the mouth, including metal fragments from occupational exposure and surgical clips in or near the brain
- Cardiac or neural pacemakers
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cathodal tDCS transcranial direct current stimulation Subjects will receive 20 minutes of active, excitatoryinhibitory transcranial direct current stimulation of the contralesional hemisphere at 1.4mA, followed by 2 hours of intensive motor therapy of the affected upper extremity. Sham tDCS transcranial direct current stimulation Subjects will receive 20 minutes of sham transcranial direct current stimulation, followed by 2 hours of intensive motor therapy of the affected upper extremity. Sham tDCS intensive upper extremity motor training Subjects will receive 20 minutes of sham transcranial direct current stimulation, followed by 2 hours of intensive motor therapy of the affected upper extremity. Dual tDCS intensive upper extremity motor training Subjects will receive 20 minutes of active, excitatory transcranial direct current stimulation of the ipsilesional hemisphere and inhibitory transcranial direct current stimulation of the contralesional hemisphere at 1.4mA, followed by 2 hours of intensive motor therapy of the affected upper extremity. Anodal tDCS intensive upper extremity motor training Subjects will receive 20 minutes of active, excitatory transcranial direct current stimulation of the ipsilesional hemisphere at 1.4mA, followed by 2 hours of intensive motor therapy of the affected upper extremity. Cathodal tDCS intensive upper extremity motor training Subjects will receive 20 minutes of active, excitatoryinhibitory transcranial direct current stimulation of the contralesional hemisphere at 1.4mA, followed by 2 hours of intensive motor therapy of the affected upper extremity. Dual tDCS transcranial direct current stimulation Subjects will receive 20 minutes of active, excitatory transcranial direct current stimulation of the ipsilesional hemisphere and inhibitory transcranial direct current stimulation of the contralesional hemisphere at 1.4mA, followed by 2 hours of intensive motor therapy of the affected upper extremity. Anodal tDCS transcranial direct current stimulation Subjects will receive 20 minutes of active, excitatory transcranial direct current stimulation of the ipsilesional hemisphere at 1.4mA, followed by 2 hours of intensive motor therapy of the affected upper extremity.
- Primary Outcome Measures
Name Time Method Change in Fugl-Meyer Assessment from baseline Baseline, Immediately post-intervention, one-month follow-up This provides a quantitative measure of motor recovery, balance, sensation, coordination, and speed. An increase in score indicates an improvement in function.
- Secondary Outcome Measures
Name Time Method Change in cortical motor map from baseline Baseline, Immediately post-intervention, one-month follow-up This is performed using non-invasive transcranial magnetic stimulation to determine which parts of the brain control a muscle in the arm.
Change in Action Research Arm Test from baseline Baseline, Immediately post-intervention, one-month follow-up This consists of 4 tests to measure grasp, grip, pinch, and gross movement. An increase in score indicates an improvement in function.
Change in Stroke Impact Scale from baseline Baseline, Immediately post-intervention, one-month follow-up This is a self-report measure of 64 items that assess 8 domains, including strength, hand function, activities of daily living, mobility, communication, emotion, memory and thinking, and participation. A score increase indicates an improvement.
Trial Locations
- Locations (1)
University of Kentucky at Cardinal Hill Rehabilitation Hospital
🇺🇸Lexington, Kentucky, United States