tDCS and Physical Therapy in Stroke

Sponsor

Beth Israel Deaconess Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00542256

Collaborator

(none)

Enrollment

Location

Arms

86.3

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebrovascular Accident	Device: Active transcranial Direct Current Stimulation / Constraint Induced Movement Therapy Device: Sham transcranial Direct Current Stimulation / Constraint Induced Movement Therapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

85 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2007

Actual Primary Completion Date :

Nov 10, 2014

Actual Study Completion Date :

Nov 10, 2014

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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