tDCS and Physical Therapy in Stroke - Full Text View

Sponsored by:	Beth Israel Deaconess Medical Center
Information provided by:	Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00542256

Purpose

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.

Condition	Intervention	Phase
Cerebrovascular Accident	Device: Active transcranial Direct Current Stimulation / Constraint Induced Movement Therapy Device: Sham transcranial Direct Current Stimulation / Constraint Induced Movement Therapy	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment
Official Title:	Effects of Transcranial DC Stimulation Coupled With Constraint Induced Movement Therapy on Motor Function in Stroke Patients

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:

Jebsen-Taylor Hand Function Test [ Time Frame: Baseline, Treatment days 1,5,10, Follow Up ]
Motor Activity Log Rating Scale [ Time Frame: Baseline, Treatment Days 1,5,10 and Follow Up ]
Beck Depression Inventory [ Time Frame: 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 ]

Secondary Outcome Measures:

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

Estimated Enrollment:	50
Study Start Date:	September 2007

Arms	Assigned Interventions
1: Active Comparator 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.
2: Sham Comparator 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.

Arms

Assigned Interventions

1: Active Comparator

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.

2: Sham Comparator

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542256

Contacts

Contact: Julie A Williams, M.Sc.

617-667-5261

jawillia@bidmc.harvard.edu

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Felipe Fregni, MD, PhD
Sub-Investigator: Alvaro Pascual-Leone, MD, PhD
Sub-Investigator: Asli Demirtas, MD
Sub-Investigator: Mariana Lopes, MD
Sub-Investigator: Julie A Williams, M.Sc.

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Investigators

Principal Investigator:

Felipe Fregni, MD, PhD

Beth Israel Deaconess Medical Center

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	0735535T
Study First Received:	October 10, 2007
Last Updated:	May 9, 2008
ClinicalTrials.gov Identifier:	NCT00542256
Health Authority:	United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:

Apoplexy
Cerebral Stroke
Cerebrovascular Accident, Acute
Cerebrovascular Apoplexy
Cerebrovascular Stroke

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

Study placed in the following topic categories:

Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Brain Ischemia

Ischemia
Brain Infarction
Brain Diseases
Infarction
Cerebrovascular Disorders

Additional relevant MeSH terms:

Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009