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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Transcranial direct current stimulation (tDCS)

• Registration Number: NCT02460809
• Lead Sponsor: University of Minnesota

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-05-29
• Study First Submitted QC: 2015-05-29
• Study First Posted: 2015-06-02
• Study Start: 2017-01-01
• Primary Completion: 2017-05-01
• Study Completion: 2017-05-01
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-09
• Last Update Posted: 2019-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

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Exclusion Criteria

• seizure within past two years
• pregnancy
• metal inside the had (dental metal is permitted)
• implanted medical devices incompatible with tDCS

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
In-lab tDCS	Transcranial direct current stimulation (tDCS)	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.
In-home tDCS	Transcranial direct current stimulation (tDCS)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Survey of symptoms questionnaire	Each day of study as well as one day following the final treatment

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States