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Completed

NCT Number: NCT00542256

tDCS and Physical Therapy in Stroke

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.

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Key information

Conditions

Cerebrovascular Accident Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active transcranial Direct Current Stimulation / Constraint Induced Movement Therapy

Device

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 transcranial Direct Current Stimulation / Constraint Induced Movement Therapy

Device

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 outcomes

  1. Jebsen-Taylor Hand Function Test

    Time frame: Baseline, Treatment days 1,5,10, Follow Up

  2. Motor Activity Log Rating Scale

    Time frame: Baseline, Treatment Days 1,5,10 and Follow Up

  3. Beck Depression Inventory

    Time frame: Baseline, Treatment days 1,5,10 and Follow up

  4. Visual Analogue Scale for Anxiety

    Time frame: Baseline, Treatment days 1,5,10 and Follow Up

Secondary outcomes

  1. Fugl Meyer Assessment of Motor Recovery

    Time frame: Baseline Assessment

  2. Barthel Index Score

    Time frame: Baseline Assessment

  3. Modified Ashworth Scale

    Time frame: Baseline Assessment

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
Oct 11, 2007
Registry last updated
Mar 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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