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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial direct current stimulation (tDCS)
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

In-lab tDCS

In-home tDCS

Arm 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.

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.

Outcomes

Primary Outcome Measures

Digit Span
Short-term memory test using single numerical digits
Box and block
Finger dexterity test using both paretic and nonparetic hands
Quantification of Compliance Questionnaire
User perception survey
Survey

Secondary Outcome Measures

Survey of symptoms questionnaire

Full Information

First Posted
May 29, 2015
Last Updated
May 9, 2019
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT02460809
Brief Title
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

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
May 1, 2017 (Actual)
Study Completion Date
May 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
In-lab tDCS
Arm Type
Active Comparator
Arm 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 Title
In-home tDCS
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation (tDCS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Digit Span
Description
Short-term memory test using single numerical digits
Time Frame
First day of study and one day following the final treatment
Title
Box and block
Description
Finger dexterity test using both paretic and nonparetic hands
Time Frame
First day of study and one day following the final treatment
Title
Quantification of Compliance Questionnaire
Time Frame
First day of study and one day following the final treatment
Title
User perception survey
Description
Survey
Time Frame
First day of study and one day following the final treatment
Secondary Outcome Measure Information:
Title
Survey of symptoms questionnaire
Time Frame
Each day of study as well as one day following the final treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Carey, PhD, PT
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30227864
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.
Results Reference
derived

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

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