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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Gottfried Schlaug, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00792428
First received: November 17, 2008
Last updated: June 10, 2017
Last verified: June 2017
  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 traditional physical-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) - in a dual configuration - vs sham (pretend) tDCS to the motor brain regions on both hemispheres - in a dual configuration - 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 PT-OT once a day for 5 days. Assessments will be done about 3 days and 7 days after the end of the experimental treatment 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 PT-OT results in a subsequent improvement in motor function of the recovering hand over sham tDCS in combination with PT-OT.

Condition Intervention
Stroke Cerebrovascular Accident CVA Acute Stroke Acute Cerebrovascular Accident Apoplexy Device: Real Transcranial Direct Current Stimulation Device: Sham Transcranial Direct Current Stimulation

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

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

Primary Outcome Measures:
  • Fugl-Meyer Assessment of Upper Extremity Motor Impairment [ Time Frame: Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days ]
    This scale goes from 0 to 66 (max). Higher values are considered to be a better outcome.


Secondary Outcome Measures:
  • Wolf-Motor-Function-Test [ Time Frame: Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days ]
    The Wolf-Motor-Function-Test (time) is the average time in seconds taken to perform each of 15 functional tasks ranging in difficulty from putting one's forearm on a table to stacking checkers. Participants are given 120 seconds to perform a task and if they fail, they are scored 120 for that task," or similar as accurate. The average time in seconds is then log10 transformed.


Enrollment: 20
Study Start Date: June 2006
Estimated Study Completion Date: December 2017
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Real-tDCS + PT-OT
Each subject will receive up to 5 days of traditional physical-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 motor region for up to 30 min.
Device: Real 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 + PT-OT
Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with sham (pretend) tDCS for up to 30 min. over the motor region.
Device: Sham 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   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • First time clinical ischemic stroke or cerebrovascular accident
  • At least 5 months out from first ischemic stroke prior to study enrollment

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

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center / Harvard Medical School
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Gottfried Schlaug, MD, PhD Beth Israel Deaconess Medical Center / Harvard Medical School
  More Information

Publications:
Responsible Party: Gottfried Schlaug, Associate Professor of Neurology; Staff Neurologist, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00792428     History of Changes
Other Study ID Numbers: 2005P000346
R01NS045049 ( U.S. NIH Grant/Contract )
Study First Received: November 17, 2008
Results First Received: April 14, 2017
Last Updated: June 10, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Gottfried Schlaug, 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:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 23, 2017