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tDCS and Physical Therapy in Stroke

Primary Purpose

Cerebrovascular Accident

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Active transcranial Direct Current Stimulation / Constraint Induced Movement Therapy

Sham transcranial Direct Current Stimulation / Constraint Induced Movement Therapy

About this trial

This is an interventional treatment trial for Cerebrovascular Accident focused on measuring Apoplexy, Cerebral Stroke, Cerebrovascular Accident, Acute, Cerebrovascular Apoplexy, Cerebrovascular Stroke, CVA (Cerebrovascular Accident), Stroke, Stroke, Acute, Vascular Accident, Brain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

First time clinical ischemic or hemorrhagic cerebrovascular accident (radiologically confirmed)
Demonstrates adequate balance while wearing a hand restraint on the unaffected arm
Ability to stand from a sitting position and ability to stand with or without upper extremity support
Stroke onset at least 6 months prior to study enrollment

Exclusion Criteria:

Significant pre-stroke disability
Any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing
Excessive pain in any joint of the paretic extremity
A terminal medical diagnosis consistent with survival of less than 1 year
Advanced liver, kidney, cardiac, or pulmonary disease
Coexistent major neurological or psychiatric disease (including epilepsy)
A history of significant alcohol or drug abuse in the prior 3 years
Use of neuropsychotropic drugs - such as antidepressants
Patients may not be actively enrolled in a separate intervention study targeting stroke recovery
Patients may not have already received constraint-induced movement therapy and/or tDCS treatment for stroke

Sites / Locations

Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Arm Description

Each subject will receive 14 days (2 week period: 10 weekdays and 2 weekends) of constraint induced movement therapy. In addition, on the 10 weekdays during the treatment period, the subjects will come into the laboratory and receive up to 6 hours per day of training of the affected arm in a variety of tasks. At the beginning of each of the 10 weekday training sessions, participants will receive 40 minutes of active tDCS over the primary motor cortex.

Each subject will receive 14 days (2 week period: 10 weekdays and 2 weekends) of constraint induced movement therapy. In addition, on the 10 weekdays during the treatment period, the subjects will come into the laboratory and receive up to 6 hours per day of training of the affected arm in a variety of tasks. At the beginning of each training day tDCS will be applied for 40 minutes with the current active for only 30 seconds over the primary motor cortex.

Outcomes

Primary Outcome Measures

Jebsen-Taylor Hand Function Test

Motor Activity Log Rating Scale

Beck Depression Inventory

Visual Analogue Scale for Anxiety

Secondary Outcome Measures

Fugl Meyer Assessment of Motor Recovery

Barthel Index Score

Modified Ashworth Scale

Full Information

NCT ID

NCT00542256

First Posted

October 10, 2007

Last Updated

March 17, 2017

Sponsor

Beth Israel Deaconess Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00542256

Brief Title

tDCS and Physical Therapy in Stroke

Official Title

Effects of Transcranial DC Stimulation Coupled With Constraint Induced Movement Therapy on Motor Function in Stroke Patients

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

November 10, 2014 (Actual)

Study Completion Date

November 10, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beth Israel Deaconess Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine whether a painless and noninvasive procedure called transcranial direct current stimulation (tDCS) combined with a method of physical therapy called constraint-induced movement therapy improves motor function in patients with chronic stroke. Research in healthy subjects has shown that when tDCS is combined with motor learning tasks, there is an increase in learning as compared to motor learning tasks only. The tDCS procedure sessions will be compared to sham (fake) procedure sessions, which is also called placebo stimulation. This study is double blind, which means neither the subjects nor researchers analyzing motor function will know if participants are receiving real tDCS stimulation or placebo. Only the person performing the procedure will know which one participants are receiving. Only by comparing the tDCS procedure to a sham (placebo) procedure can we understand if the tDCS actually improves motor function. We hypothesize that tDCS will enhance the effects of constraint-induced movement therapy on motor recovery in chronic stroke patients.

6. Conditions and Keywords

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

Cerebrovascular Accident

Keywords

Apoplexy, Cerebral Stroke, Cerebrovascular Accident, Acute, Cerebrovascular Apoplexy, Cerebrovascular Stroke, CVA (Cerebrovascular Accident), Stroke, Stroke, Acute, Vascular Accident, Brain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

85 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Arm Title

Arm Type

Sham Comparator

Arm Description

Each subject will receive 14 days (2 week period: 10 weekdays and 2 weekends) of constraint induced movement therapy. In addition, on the 10 weekdays during the treatment period, the subjects will come into the laboratory and receive up to 6 hours per day of training of the affected arm in a variety of tasks. At the beginning of each training day tDCS will be applied for 40 minutes with the current active for only 30 seconds over the primary motor cortex.

Intervention Type

Device

Intervention Name(s)

Active transcranial Direct Current Stimulation / Constraint Induced Movement Therapy

Intervention Description

14 days of constraint induced movement therapy with 10 weekdays of up to 6 hours of training of the affected arm combined with application of tDCS over the primary motor cortex for 40 minutes.

Intervention Type

Device

Intervention Name(s)

Sham transcranial Direct Current Stimulation / Constraint Induced Movement Therapy

Intervention Description

14 days of constraint induced movement therapy with 10 days of up to 6 hours of training in the affected arm and sham tDCS applied over the primary motor cortex for 40 minutes with active current applied for 30 seconds.

Primary Outcome Measure Information:

Title

Jebsen-Taylor Hand Function Test

Time Frame

Baseline, Treatment days 1,5,10, Follow Up

Title

Motor Activity Log Rating Scale

Time Frame

Baseline, Treatment Days 1,5,10 and Follow Up

Title

Beck Depression Inventory

Time Frame

Baseline, Treatment days 1,5,10 and Follow up

Title

Visual Analogue Scale for Anxiety

Time Frame

Baseline, Treatment days 1,5,10 and Follow Up

Secondary Outcome Measure Information:

Title

Fugl Meyer Assessment of Motor Recovery

Time Frame

Baseline Assessment

Title

Barthel Index Score

Time Frame

Baseline Assessment

Title

Modified Ashworth Scale

Time Frame

Baseline Assessment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: First time clinical ischemic or hemorrhagic cerebrovascular accident (radiologically confirmed) Demonstrates adequate balance while wearing a hand restraint on the unaffected arm Ability to stand from a sitting position and ability to stand with or without upper extremity support Stroke onset at least 6 months prior to study enrollment Exclusion Criteria: Significant pre-stroke disability Any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing Excessive pain in any joint of the paretic extremity A terminal medical diagnosis consistent with survival of less than 1 year Advanced liver, kidney, cardiac, or pulmonary disease Coexistent major neurological or psychiatric disease (including epilepsy) A history of significant alcohol or drug abuse in the prior 3 years Use of neuropsychotropic drugs - such as antidepressants Patients may not be actively enrolled in a separate intervention study targeting stroke recovery Patients may not have already received constraint-induced movement therapy and/or tDCS treatment for stroke

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Felipe Fregni, MD, PhD

Organizational Affiliation

Beth Israel Deaconess Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beth Israel Deaconess Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

33175411

Citation

Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.

Results Reference

derived

Links:

URL

http://www.tmslab.org

Description

Related Info

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