tDCS and Physical Therapy in Stroke

Cerebrovascular Accident Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00542256
• Other study ID #: 2007P000420
• Status: Completed
• Phase: N/A
• First received: October 10, 2007
• Last updated: March 17, 2017
• Start date: September 2007
• Est. completion date: November 10, 2014

Study information

• Verified date: March 2017
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: November 10, 2014
• Est. primary completion date: November 10, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

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 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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Jebsen-Taylor Hand Function Test		Baseline, Treatment days 1,5,10, Follow Up
Primary	Motor Activity Log Rating Scale		Baseline, Treatment Days 1,5,10 and Follow Up
Primary	Beck Depression Inventory		Baseline, Treatment days 1,5,10 and Follow up
Primary	Visual Analogue Scale for Anxiety		Baseline, Treatment days 1,5,10 and Follow Up
Secondary	Fugl Meyer Assessment of Motor Recovery		Baseline Assessment
Secondary	Barthel Index Score		Baseline Assessment
Secondary	Modified Ashworth Scale		Baseline Assessment

External Links

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