tDCS and Physical Therapy in Stroke

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ClinicalTrials.gov Identifier: NCT00542256

Recruitment Status : Completed

First Posted : October 11, 2007

Last Update Posted : March 21, 2017

Sponsor:

Information provided by (Responsible Party):

Felipe Fregni, Beth Israel Deaconess Medical Center

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	Not Applicable

Study Design


Study Type :	Interventional (Clinical Trial)
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 :	September 2007
Actual Primary Completion Date :	November 10, 2014
Actual Study Completion Date :	November 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 [ 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00542256

Locations


United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Investigators


Principal Investigator:	Felipe Fregni, MD, PhD	Beth Israel Deaconess Medical Center

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site


Responsible Party:	Felipe Fregni, Study Principal Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00542256 History of Changes
Other Study ID Numbers:	2007P000420
First Posted:	October 11, 2007 Key Record Dates
Last Update Posted:	March 21, 2017
Last Verified:	March 2017


Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Felipe Fregni, Beth Israel Deaconess Medical Center:


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

Additional relevant MeSH terms:


Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases	Nervous System Diseases Vascular Diseases Cardiovascular Diseases

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