Trial record 2 of 986 for:    Open Studies | "Stroke"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Beth Israel Deaconess Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00792428
First received: November 17, 2008
Last updated: June 30, 2011
Last verified: June 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 August 20, 2014