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

NCT02460809 | Completed DMC FDA Device

• 1 other identifier: Home tDCS
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (4)

• Digit Span

  Short-term memory test using single numerical digits

  First day of study and one day following the final treatment

• Box and block

  Finger dexterity test using both paretic and nonparetic hands

  First day of study and one day following the final treatment

• Quantification of Compliance Questionnaire

  First day of study and one day following the final treatment

• User perception survey

  Survey

  First day of study and one day following the final treatment

Secondary Outcomes (1)

• Survey of symptoms questionnaire

  Each day of study as well as one day following the final treatment

Study Arms (2)

In-lab tDCS

ACTIVE COMPARATOR

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.

Device: Transcranial direct current stimulation (tDCS)

In-home tDCS

EXPERIMENTAL

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.

Device: Transcranial direct current stimulation (tDCS)

Interventions

Transcranial direct current stimulation (tDCS) DEVICE

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.

In-home tDCS; In-lab tDCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• 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.

  PMID: 30227864 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• James Carey, PhD, PT

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: June 2, 2015
• Study Start: January 1, 2017
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: May 13, 2019

Record last verified: 2019-05

Locations

US (1)