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

tDCS and Physical Therapy in Stroke

Sponsors

Lead sponsor: Beth Israel Deaconess Medical Center

Source 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.

Overall Status Completed
Start Date September 2007
Completion Date November 10, 2014
Primary Completion Date November 10, 2014
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Measure Time Frame
Fugl Meyer Assessment of Motor Recovery Baseline Assessment
Barthel Index Score Baseline Assessment
Modified Ashworth Scale Baseline Assessment
Enrollment 85
Condition
Intervention

Intervention type: Device

Intervention name: Active transcranial Direct Current Stimulation / Constraint Induced Movement Therapy

Description: 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.

Arm group label: 1

Intervention type: Device

Intervention name: Sham transcranial Direct Current Stimulation / Constraint Induced Movement Therapy

Description: 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 group label: 2

Eligibility

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

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Felipe Fregni, MD, PhD Principal Investigator Beth Israel Deaconess Medical Center
Location
facility Beth Israel Deaconess Medical Center
Location Countries

United States

Verification Date

March 2017

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Beth Israel Deaconess Medical Center

Investigator full name: Felipe Fregni

Investigator title: Study Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: 1

Arm group type: Active Comparator

Description: 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.

Arm group label: 2

Arm group type: Sham Comparator

Description: 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.

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Source: ClinicalTrials.gov