tDCS and Physical Therapy in Stroke

March 17, 2017 updated by: Felipe Fregni, Beth Israel Deaconess Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
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.
Device: Active transcranial Direct Current Stimulation / Constraint Induced Movement Therapy
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.
Sham Comparator: 2
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.
Device: Sham transcranial Direct Current Stimulation / Constraint Induced Movement Therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Jebsen-Taylor Hand Function Test
Time Frame: Baseline, Treatment days 1,5,10, Follow Up
Baseline, Treatment days 1,5,10, Follow Up
Motor Activity Log Rating Scale
Time Frame: Baseline, Treatment Days 1,5,10 and Follow Up
Baseline, Treatment Days 1,5,10 and Follow Up
Beck Depression Inventory
Time Frame: Baseline, Treatment days 1,5,10 and Follow up
Baseline, Treatment days 1,5,10 and Follow up
Visual Analogue Scale for Anxiety
Time Frame: Baseline, Treatment days 1,5,10 and Follow Up
Baseline, Treatment days 1,5,10 and Follow Up

Secondary Outcome Measures

Outcome Measure
Time Frame
Fugl Meyer Assessment of Motor Recovery
Time Frame: Baseline Assessment
Baseline Assessment
Barthel Index Score
Time Frame: Baseline Assessment
Baseline Assessment
Modified Ashworth Scale
Time Frame: Baseline Assessment
Baseline Assessment

Collaborators and Investigators

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

Sponsor

Beth Israel Deaconess Medical Center

Investigators

  • Principal Investigator: Felipe Fregni, MD, PhD, Beth Israel Deaconess Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

September 1, 2007

Primary Completion (Actual)

November 10, 2014

Study Completion (Actual)

November 10, 2014

Study Registration Dates

First Submitted

October 10, 2007

First Submitted That Met QC Criteria

October 10, 2007

First Posted (Estimate)

October 11, 2007

Study Record Updates

Last Update Posted (Actual)

March 21, 2017

Last Update Submitted That Met QC Criteria

March 17, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007P000420

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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