Optimizing Transcranial Direct Current Stimulation for Motor Recovery From Severe Post-stroke Hemiparesis

January 13, 2021 updated by: Lumy Sawaki, University of Kentucky
Individuals who experienced a stroke over one year ago will be randomly assigned to receive 1 of 4 different conditions of brain stimulation. All individuals will receive therapy of the hand and arm following the stimulation. This study will try to determine which brain stimulation condition leads to the greatest improvement in hand and arm function.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This study will look at the effects of a painless, non-invasive form of brain stimulation, called transcranial direct current stimulation, or tDCS. tDCS is thought to increase the brain's ability to change. Participants will be assigned to one of four groups by chance. Three groups will receive tDCS at a level expected to increase the brain's ability to change, and will vary by the areas of the brain that are stimulated. The fourth group will receive tDCS at a level not thought to affect the brain's ability to change. All participants will receive intensive therapy of their impaired arm and hand, focusing on exercises that will improve their ability to function in daily life.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • University of Kentucky at Cardinal Hill Rehabilitation Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 12 or more months post-stroke
  • Inability to extend the affected metacarpophalangeal joints at least 10 degrees and the wrist 20 degrees

Exclusion Criteria:

  • Addition or change in dosage of drugs known to exert detrimental effects on motor recovery within 3 month of enrollment
  • Untreated depression
  • History of multiple strokes

Exclusion criteria for TMS evaluations:

  • History of head injury with loss of consciousness
  • History of severe alcohol or drug abuse, or psychiatric illness
  • Positive pregnancy test or being of childbearing age and not using appropriate contraception
  • Presence of ferromagnetic material in the cranium except in the mouth, including metal fragments from occupational exposure and surgical clips in or near the brain
  • Cardiac or neural pacemakers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anodal tDCS
Subjects will receive 20 minutes of active, excitatory transcranial direct current stimulation of the ipsilesional hemisphere at 1.4mA, followed by 2 hours of intensive motor therapy of the affected upper extremity.
Device: transcranial direct current stimulation
This is a non-invasive form of stimulation which delivers safe, low levels of electrical current to the brain through the scalp.
Behavioral: intensive upper extremity motor training
This training is administered one-on-one with an occupational therapist. Activities will be focused on skills to help the individual function better in daily life.
Experimental: Cathodal tDCS
Subjects will receive 20 minutes of active, excitatoryinhibitory transcranial direct current stimulation of the contralesional hemisphere at 1.4mA, followed by 2 hours of intensive motor therapy of the affected upper extremity.
Device: transcranial direct current stimulation
This is a non-invasive form of stimulation which delivers safe, low levels of electrical current to the brain through the scalp.
Behavioral: intensive upper extremity motor training
This training is administered one-on-one with an occupational therapist. Activities will be focused on skills to help the individual function better in daily life.
Experimental: Dual tDCS
Subjects will receive 20 minutes of active, excitatory transcranial direct current stimulation of the ipsilesional hemisphere and inhibitory transcranial direct current stimulation of the contralesional hemisphere at 1.4mA, followed by 2 hours of intensive motor therapy of the affected upper extremity.
Device: transcranial direct current stimulation
This is a non-invasive form of stimulation which delivers safe, low levels of electrical current to the brain through the scalp.
Behavioral: intensive upper extremity motor training
This training is administered one-on-one with an occupational therapist. Activities will be focused on skills to help the individual function better in daily life.
Sham Comparator: Sham tDCS
Subjects will receive 20 minutes of sham transcranial direct current stimulation, followed by 2 hours of intensive motor therapy of the affected upper extremity.
Device: transcranial direct current stimulation
This is a non-invasive form of stimulation which delivers safe, low levels of electrical current to the brain through the scalp.
Behavioral: intensive upper extremity motor training
This training is administered one-on-one with an occupational therapist. Activities will be focused on skills to help the individual function better in daily life.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fugl-Meyer Assessment from baseline
Time Frame: Baseline, Immediately post-intervention, one-month follow-up
This provides a quantitative measure of motor recovery, balance, sensation, coordination, and speed. An increase in score indicates an improvement in function.
Baseline, Immediately post-intervention, one-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Action Research Arm Test from baseline
Time Frame: Baseline, Immediately post-intervention, one-month follow-up
This consists of 4 tests to measure grasp, grip, pinch, and gross movement. An increase in score indicates an improvement in function.
Baseline, Immediately post-intervention, one-month follow-up
Change in Stroke Impact Scale from baseline
Time Frame: Baseline, Immediately post-intervention, one-month follow-up
This is a self-report measure of 64 items that assess 8 domains, including strength, hand function, activities of daily living, mobility, communication, emotion, memory and thinking, and participation. A score increase indicates an improvement.
Baseline, Immediately post-intervention, one-month follow-up
Change in cortical motor map from baseline
Time Frame: Baseline, Immediately post-intervention, one-month follow-up
This is performed using non-invasive transcranial magnetic stimulation to determine which parts of the brain control a muscle in the arm.
Baseline, Immediately post-intervention, one-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2018

Primary Completion (Actual)

January 8, 2021

Study Completion (Actual)

January 8, 2021

Study Registration Dates

First Submitted

September 28, 2020

First Submitted That Met QC Criteria

October 2, 2020

First Posted (Actual)

October 5, 2020

Study Record Updates

Last Update Posted (Actual)

January 15, 2021

Last Update Submitted That Met QC Criteria

January 13, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 47644

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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