Robots Paired With tDCS in Stroke Recovery

Study Overview
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Brief Summary
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The purpose of this study is to evaluate if multiple therapy sessions of Transcranial Direct Current Stimulation (tDCS non-invasive brain stimulation) combined with robotic arm therapy lead to a greater functional recovery in upper limb mobility after stroke than that provided by robotic arm therapy alone.

Official Title
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Effects of Transcranial Direct Current Stimulation Paired With Robotic Arm Therapy on Recovery of Upper Extremity Motor Function in Stroke Patients

Conditions
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Stroke

Intervention / Treatment
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* Device: Transcranial Direct Current Stimulation (tDCS)
* Device: Placebo sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older First single focal unilateral lesion with diagnosis verified by brain imaging, which occurred at least 6 months prior Cognitive function sufficient enough to understand experiments and follow instructions Fugl-Meyer assessment of 7 to 58 out of 66 (neither hemiplegic nor fully recovered motor function in the muscles of the shoulder, elbow, and wrist) Exclusion Criteria: Botox treatment within 6 weeks of enrollment Fixed contraction of the affected limb Complete flaccid paralysis of the affected limb History of hemorrhagic stroke Ongoing use of CNS active medications Ongoing use of psychoactive medications Presence of additional potential tDCS/TMS risk factors including damaged skin at site of stimulation, presence of a magnetically/mechanically active implant, metal in the head, family history of epilepsy, and personal history of seizures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tDCS + robotic arm therapy<br>Transcranial Direct Current Stimulation (tDCS) 2mA for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total) | Device: Transcranial Direct Current Stimulation (tDCS)<br> <br> * Other names: Soterix 1x1;|
| Placebo Comparator: tDCS sham + robotic arm therapy<br>Transcranial Direct Current Stimulation sham condition (0 mA) for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total) | Device: Placebo sham<br> <br> * Other names: tDCS sham;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Change in Upper Extremity Fugl Meyer Assessment Score | The median change in Upper Extremity Fugl-Meyer Score was calculated from baseline to discharge at 12 weeks (immediately following the intervention) and again at 36 weeks (6 months follow-up from the intervention) in each training condition (sham tDCS + robotics arm training vs. active tDCS + robotic arm training). The total Upper Extremity Fugl Meyer score is reported, with a range 0-66 points, and with higher values indicating better functional status. | baseline, discharge at 12 weeks (immediately following the intervention), and follow-up at 36 weeks (6 months after the intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Change in WOLF Motor Function Test (WMFT) | The median change in performance time for the WOLF motor function test was calculated from baseline to discharge at 12 weeks (immediately following the intervention) and again at 36 weeks (6 months follow-up from the intervention) in each training condition (sham tDCS + robotics arm training vs. active tDCS + robotic arm training). The total WOLF motor function timed score is reported here in seconds, with a range 0-1800 seconds, and with lower values indicating faster completion of task and better functional status. | baseline, discharge at 12 weeks (immediately following the intervention), and follow-up at 36 weeks (6 months after the intervention) | 
| Median Change in Motor Power Manual Muscle Test Score for the Upper Extremity (MRC) | The median change in Motor Power Manual Muscle Test Score for the upper extremity was calculated from baseline to discharge at 12 weeks (immediately following the intervention) and again at 36 weeks (6 months follow-up from the intervention) in each training condition (sham tDCS + robotics arm training vs. active tDCS + robotic arm training). The total Motor Power Manual Muscle Test Score is reported here, with a range 0-100 points, and with higher values indicating better functional status. | 12 weeks (immediately following the intervention) and 36 weeks (6 months after the intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Cerebrovascular Accident, Cerebral Stroke, CVA, Robotic therapy, Upper extremity recovery, tDCS, Non-invasive brain stimulation