Stroke
Conditions
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.
Interventions
DEVICETranscranial direct current stimulation (tDCS)
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.
Sponsors
University of Minnesota
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Digit Span | First day of study and one day following the final treatment | Short-term memory test using single numerical digits |
| 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 | — |
| User perception survey | First day of study and one day following the final treatment | Survey |
Secondary
| Measure | Time frame |
|---|---|
| Survey of symptoms questionnaire | Each day of study as well as one day following the final treatment |
Countries
United States
Outcome results
None listed