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

Stroke Clinical Trial

Official title:

Home-based tDCS and Hand Tracking Rehabilitation for Chronic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02460809
• Other study ID #: Home tDCS
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: May 1, 2017

Study information

• Verified date: May 2019
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: May 1, 2017
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Transcranial 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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Digit Span	Short-term memory test using single numerical digits	First day of study and one day following the final treatment
Primary	Box and block	Finger dexterity test using both paretic and nonparetic hands	First day of study and one day following the final treatment
Primary	Quantification of Compliance Questionnaire		First day of study and one day following the final treatment
Primary	User perception survey	Survey	First day of study and one day following the final treatment
Secondary	Survey of symptoms questionnaire		Each day of study as well as one day following the final treatment