tDCS and Physical Therapy in Stroke

Not Applicable

Completed

• Conditions: Cerebrovascular Accident
• Interventions: Device: Active transcranial Direct Current Stimulation / Constraint Induced Movement Therapy; Device: Sham transcranial Direct Current Stimulation / Constraint Induced Movement Therapy

• Registration Number: NCT00542256
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-10-10
• Study First Submitted QC: 2007-10-10
• Study First Posted: 2007-10-11
• Primary Completion: 2014-11-10
• Study Completion: 2014-11-10
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-17
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Active transcranial Direct Current Stimulation / Constraint Induced Movement Therapy	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.
2	Sham transcranial Direct Current Stimulation / Constraint Induced Movement Therapy	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.

Primary Outcome Measures

Name	Time	Method
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
Jebsen-Taylor Hand Function Test	Baseline, Treatment days 1,5,10, Follow Up

Secondary Outcome Measures

Name	Time	Method
Fugl Meyer Assessment of Motor Recovery	Baseline Assessment
Modified Ashworth Scale	Baseline Assessment
Barthel Index Score	Baseline Assessment

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States