Clinical trial NCT02460809: Home-based Non-invasive Brain Stimulation and Hand Tracking Rehabilitation for People With Chronic Stroke
Official title: Home-based tDCS and Hand Tracking Rehabilitation for Chronic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2015-06-02
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: Digit Span
timeFrame: First day of study and one day following the final treatment
measure: Box and block
timeFrame: First day of study and one day following the final treatment
measure: Quantification of Compliance Questionnaire
timeFrame: First day of study and one day following the final treatment
measure: User perception survey
timeFrame: First day of study and one day following the final treatment
Secondary outcomes:
measure: Survey of symptoms questionnaire
timeFrame: Each day of study as well as one day following the final treatment
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: James Carey, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van de Winckel A, Carey JR, Bisson TA, Hauschildt EC, Streib CD, Durfee WK. Home-based transcranial direct current stimulation plus tracking training therapy in people with stroke: an open-label feasibility study. J Neuroeng Rehabil. 2018 Sep 18;15(1):83. doi: 10.1186/s12984-018-0427-2.