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

Primary Purpose

Stroke, Hemiparesis

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

transcranial direct current stimulation

intensive upper extremity motor training

About this trial

This is an interventional treatment trial for Stroke focused on measuring neuroplasticity, rehabilitation, transcranial direct current stimulation, motor training

Eligibility Criteria

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

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

Sites / Locations

University of Kentucky at Cardinal Hill Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Arm Label

Anodal tDCS

Cathodal tDCS

Dual tDCS

Sham tDCS

Arm Description

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.

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.

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.

Subjects will receive 20 minutes of sham transcranial direct current stimulation, followed by 2 hours of intensive motor therapy of the affected upper extremity.

Outcomes

Primary Outcome Measures

Change in Fugl-Meyer Assessment from baseline

This provides a quantitative measure of motor recovery, balance, sensation, coordination, and speed. An increase in score indicates an improvement in function.

Secondary Outcome Measures

Change in Action Research Arm Test from baseline

This consists of 4 tests to measure grasp, grip, pinch, and gross movement. An increase in score indicates an improvement in function.

Change in Stroke Impact Scale from baseline

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.

Change in cortical motor map from baseline

This is performed using non-invasive transcranial magnetic stimulation to determine which parts of the brain control a muscle in the arm.

Full Information

NCT ID

NCT04574973

First Posted

September 28, 2020

Last Updated

January 13, 2021

Sponsor

University of Kentucky

1. Study Identification

Unique Protocol Identification Number

NCT04574973

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Terminated

Why Stopped

Relocation of PI

Study Start Date

November 28, 2018 (Actual)

Primary Completion Date

January 8, 2021 (Actual)

Study Completion Date

January 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Kentucky

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

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

Stroke, Hemiparesis

Keywords

neuroplasticity, rehabilitation, transcranial direct current stimulation, motor training

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Anodal tDCS

Arm Type

Experimental

Arm Description

Arm Title

Cathodal tDCS

Arm Type

Experimental

Arm Description

Arm Title

Dual tDCS

Arm Type

Experimental

Arm Description

Arm Title

Sham tDCS

Arm Type

Sham Comparator

Arm Description

Subjects will receive 20 minutes of sham transcranial direct current stimulation, followed by 2 hours of intensive motor therapy of the affected upper extremity.

Intervention Type

Device

Intervention Name(s)

transcranial direct current stimulation

Intervention Description

This is a non-invasive form of stimulation which delivers safe, low levels of electrical current to the brain through the scalp.

Intervention Type

Behavioral

Intervention Name(s)

intensive upper extremity motor training

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Fugl-Meyer Assessment from baseline

Description

This provides a quantitative measure of motor recovery, balance, sensation, coordination, and speed. An increase in score indicates an improvement in function.

Time Frame

Baseline, Immediately post-intervention, one-month follow-up

Secondary Outcome Measure Information:

Title

Change in Action Research Arm Test from baseline

Description

This consists of 4 tests to measure grasp, grip, pinch, and gross movement. An increase in score indicates an improvement in function.

Time Frame

Baseline, Immediately post-intervention, one-month follow-up

Title

Change in Stroke Impact Scale from baseline

Description

Time Frame

Baseline, Immediately post-intervention, one-month follow-up

Title

Change in cortical motor map from baseline

Description

This is performed using non-invasive transcranial magnetic stimulation to determine which parts of the brain control a muscle in the arm.

Time Frame

Baseline, Immediately post-intervention, one-month follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

University of Kentucky at Cardinal Hill Rehabilitation Hospital

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40504

Country

United States

12. IPD Sharing Statement

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

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