Non-invasive Brain Stimulation and Occupational Therapy To Enhance Stroke Recovery - Full Text View

Purpose

The purpose of this study is to determine whether a non-painful, non-invasive, brain-stimulation technique called transcranial direct current stimulation (tDCS) combined with occupational therapy (OT) will improve motor function in patients with chronic stroke. The aim is to determine the effect of applying real (anodal and/or cathodal) vs sham (pretend) tDCS to the motor brain region to improve motor function in chronic stroke patients. Our research in normal subjects has shown that motor skills can be enhanced if tDCS is applied to the brain's motor region during motor learning. The effects after a single session of tDCS can last for up to 30 minutes, effects of multiple sessions (one session per day) can last for weeks. Furthermore, single sessions of tDCS applied to the motor regions in stroke patients have shown that improvements in motor functions can be seen and that effects may last for at least 30 minutes. Patients enrolled in this trial will be randomized to receive either real tDCS or sham tDCS in combination with OT once a day for up to 10 days. Assessments will be done by investigators who are blinded to the intervention. Patients are also blinded as to whether they are receiving real or sham tDCS. We hypothesize that real tDCS applied to the motor regions in combination with OT results in a subsequent improvement in motor function of the recovering hand over sham tDCS in combination with OT.

Condition	Intervention	Phase
Stroke Cerebrovascular Accident CVA Acute Stroke Acute Cerebrovascular Accident Apoplexy	Device: Transcranial Direct Current Stimulation Device: Transcranial Direct Current Stimulation	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Facilitating Motor Recovery After Stroke Using tDCS

Resource links provided by NLM:

MedlinePlus related topics: Neurologic Diseases

U.S. FDA Resources

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:

3-Joint Range of Motion (3J-ROM) [ Time Frame: Two Baseline Assessments; Treatment days 5, 10; Follow Up ] [ Designated as safety issue: No ]
Fugl-Meyer Assessment of Upper Extremity Motor Impairment [ Time Frame: Two Baseline Assessments; Treatment days 5, 10; Follow-Up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Wolf-Motor-Function-Test [ Time Frame: Two Baseline Assessments; Treatment days 5, 10; Follow-up ] [ Designated as safety issue: No ]
Functional MRI Activation Pattern [ Time Frame: Baseline; Follow-up ] [ Designated as safety issue: No ]
Diffusion Tensor Imaging [ Time Frame: Baseline; Follow-up ] [ Designated as safety issue: No ]
Transcranial Magnetic Stimulation (TMS) [ Time Frame: Baseline; Follow-up ] [ Designated as safety issue: No ]
Motor Activity Log Rating Scales [ Time Frame: 2 Baseline Assessments; Treatment Days 5, 10; Follow-up ] [ Designated as safety issue: No ]
Modified Ashworth Scale [ Time Frame: Baseline; Treatment days 5, 10 ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	June 2006
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Real-tDCS + Occupational Therapy Each subject will receive up to 10 days of traditional occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with real transcranial direct current stimulation (tDCS) over the primary motor region for up to 45 min.	Device: Transcranial Direct Current Stimulation A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue Other Names: Non-invasive brain stimulation Brain stimulation Enhancing stroke recovery
Sham Comparator: Sham-tDCS + Occupational Therapy Each subject will receive up to 10 days of traditional occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with sham (pretend) tDCS for up to 45 min. over the primary motor region.	Device: Transcranial Direct Current Stimulation A sham current runs between two electrode positions and might affect the underlying brain tissue. Other Names: Non-invasive brain stimulation Brain stimulation Enhancing stroke recovery

Eligibility

Ages Eligible for Study:	21 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

First time clinical ischemic stroke or cerebrovascular accident
At least 6 months out from first ischemic stroke prior to study enrollment
Healthy control volunteer who has not suffered a stroke

Exclusion Criteria:

More than 1 stroke (older strokes)
Significant pre-stroke disability
A terminal medical illness or disorder with survival of less than 1 year
Co-existent major neurological or psychiatric diseases (e.g., epilepsy)
Use of psychoactive drugs/medications - such as antidepressants,antipsychotic, stimulating agents
Active participation in other stroke recovery trials testing interventions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00792428

Contacts

Contact: Gottfried Schlaug, MD, PhD	617-632-8917	stroke_recovery@yahoo.com
Contact: Andrea Norton, BM	617 632-8926	stroke_recovery@yahoo.com

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center / Harvard Medical School	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Gottfried Schlaug, MD, PhD 617-632-8917 gschlaug@bidmc.harvard.edu
Contact: Andrea Norton 617 632-8926 stroke_recovery@yahoo.com
Sub-Investigator: Robert Lindenberg, MD, PhD
Sub-Investigator: Vijay Renga, MD
Sub-Investigator: Dinesh Nair, MD, PhD

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Investigators

Principal Investigator:

Gottfried Schlaug, MD, PhD

Beth Israel Deaconess Medical Center / Harvard Medical School

More Information

Publications:

Vines BW, Nair D, Schlaug G. Modulating activity in the motor cortex affects performance for the two hands differently depending upon which hemisphere is stimulated. Eur J Neurosci. 2008 Oct;28(8):1667-73.

Vines BW, Cerruti C, Schlaug G. Dual-hemisphere tDCS facilitates greater improvements for healthy subjects' non-dominant hand compared to uni-hemisphere stimulation. BMC Neurosci. 2008 Oct 28;9(1):103 [Epub ahead of print]

Nair DG, Hutchinson S, Fregni F, Alexander M, Pascual-Leone A, Schlaug G. Imaging correlates of motor recovery from cerebral infarction and their physiological significance in well-recovered patients. Neuroimage. 2007 Jan 1;34(1):253-63. Epub 2006 Oct 27.

Vines BW, Nair DG, Schlaug G. Contralateral and ipsilateral motor effects after transcranial direct current stimulation. Neuroreport. 2006 Apr 24;17(6):671-4.

Responsible Party:	Gottfried Schlaug, MD, PhD; Associate Professor of Neurology, Beth Israel Deaconess Medical Center / Harvard Medical School
ClinicalTrials.gov Identifier:	NCT00792428 History of Changes
Other Study ID Numbers:	2005P-000346, NS45049
Study First Received:	November 17, 2008
Last Updated:	June 30, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:

Stroke
Ischemia
Infarction
Cerebrovascular Disorder
Central Nervous System Diseases
Brain Infarction

Brain Ischemia
Rehabilitation
Recovery
Neurorehabilitation
Plasticity

Additional relevant MeSH terms:

Cerebral Infarction
Stroke
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders

Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013

Non-invasive Brain Stimulation and Occupational Therapy To Enhance Stroke Recovery (TDCS+OT)