Home-based Non-invasive Brain Stimulation and Hand Tracking Rehabilitation for People With Chronic Stroke

Study Overview
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Brief Summary
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This is a device feasibility study, which will assess telerehabilitation in people with chronic stroke using a combination of noninvasive brain stimulation and finger tracking training. Telerehabilitation allows patients to train in their own home which also allows for longer training periods than what is currently allowed clinically. Noninvasive transcranial direct current stimulation (tDCS) uses two surface electrodes connected to a small battery that will be attached to the head. This will be used to modulate neuronal excitability. With sensors attached to fingers and the wrist, the patient will move the joints to track a target displayed on a screen. The combined treatment will be applied in two experiments. The first will be on 3 patients coming to our lab and the second on 3 patients in their home, both under supervision. We will integrate the two components and test the resulting and novel treatment system for technical feasibility, which will set the stage for future efficacy studies under federal grant support. We hypothesize that the developed system will be safe and feasible.

Detailed Description
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This study will assess the feasibility of a telerehabilitation protocol involving non-invasive brain stimulation. Therefore, the two arms of the study are 1) implementation of this protocol in a controlled laboratory setting and 2) implementation of this protocol in a patient's home, being set up by the patient but controlled remotely using a blue-tooth system by an investigator in a different location. The two arms of this study will occur successively with the first arm being completed with three patients followed by the second arm being completed with a second group of three patients.

Official Title
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Home-based tDCS and Hand Tracking Rehabilitation for Chronic Stroke

Conditions
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Stroke

Intervention / Treatment
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* Device: Transcranial direct current stimulation (tDCS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult at least 18 years old stroke duration >6 months, Mini-Mental State Examination score 24 or higher presence of tactile sensation on the scalp at least 10 degrees of active finger or wrist motion in the stroke hand ability to walk 100 feet and transfer independently Exclusion Criteria: seizure within past two years pregnancy metal inside the had (dental metal is permitted) implanted medical devices incompatible with tDCS

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: Device Feasibility
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: In-lab tDCS<br>Three people with chronic stroke will participate in finger tracking training while receiving transcranial direct current stimulation (tDCS) in a controlled laboratory environment with an investigator. | Device: Transcranial direct current stimulation (tDCS)<br>* Transcranial direct current stimulation (tDCS) uses two surface electrodes placed on the scalp. These electrodes pass a low voltage current and modulate membrane potentials of underlying neurons.<br>|
| Experimental: In-home tDCS<br>Three people with chronic stroke will participate in finger tracking training while receiving transcranial direct current stimulation (tDCS) in their own home. Patients will be taught how to use a blue-tooth enabled telerehabilitation module that is being controlled by an investigator in the lab on the University campus. For safety, an investigator will be in the home with each patient during tDCS use and finger tracking training but will only be supervising procedures. | Device: Transcranial direct current stimulation (tDCS)<br>* Transcranial direct current stimulation (tDCS) uses two surface electrodes placed on the scalp. These electrodes pass a low voltage current and modulate membrane potentials of underlying neurons.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Digit Span | Short-term memory test using single numerical digits | First day of study and one day following the final treatment | 
| Box and block | Finger dexterity test using both paretic and nonparetic hands | First day of study and one day following the final treatment | 
| Quantification of Compliance Questionnaire |  | First day of study and one day following the final treatment | 
| User perception survey | Survey | First day of study and one day following the final treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survey of symptoms questionnaire |  | Each day of study as well as one day following the final treatment |