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

Recruiting

Phase N/A Results N/A

Trial Description

This study assesses 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 and safety, 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

This study will assess the safety and 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.

Conditions

Interventions

  • Transcranial direct current stimulation (tDCS) Device
    Other Names: tDCS; Brain Stimulation
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: In-lab tDCS
    Description: 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.
    ARM 2: Kind: Experimental
    Label: In-home tDCS
    Description: 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.

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Digit Span First day of study and one day following the final treatment Yes
Primary Box and block First day of study and one day following the final treatment Yes
Primary Quantification of Compliance First day of study and one day following the final treatment No
Primary User perception survey First day of study and one day following the final treatment No
Secondary Survey of symptoms questionnaire Each day of study as well as one day following the final treatment Yes
Primary Quantification of Compliance Questionnaire First day of study and one day following the final treatment No

Sponsors