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Transcranial Direct Current Stimulation (tDCS) in Chronic Stroke Recovery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of Texas Southwestern Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01014897
First received: November 2, 2009
Last updated: August 2, 2011
Last verified: June 2010
History of Changes
  Purpose

The hypothesis of this study is that different subgroups of stroke will respond differently to direct current stimulation.


Condition Intervention Phase
Stroke
 Device: tDCS
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: tDCS in Chronic Stroke Recovery-pilot

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Wolf Motor Function test [ Time Frame: immediately before and immediately after treatment ] [ Designated as safety issue: No ]
  • Fugl-Meyer [ Time Frame: immediately before and immediately after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adverse events [ Time Frame: immediately before and immediately after treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: April 2009
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: subcortical
Subcortical stroke patients will receive tDCS stimulation and sham in random order
 Device: tDCS
tDCS and sham will be applied in random order during standardized occupational therapy
Other Name: transcranial direct current stimulation
Experimental: cortical
subjects will receive active and sham tDCS in random order
 Device: tDCS
tDCS and sham will be applied in random order during standardized occupational therapy
Other Name: transcranial direct current stimulation

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • single symptomatic stroke more than 3 months ago with hand/arm weakness
  • able to perform required tests and provide consent
  • Age 18-80
  • Modified Ashworth scale <3
  • ROM functional at shoulder elbow wrist and hand

Exclusion Criteria:

  • more than one symptomatic stroke in MCA territory or bilateral involvement
  • severe medical or psychiatric conditions, drug abuse, seizure disorder
  • pregnancy/breast feeding
  • SAH, lobar hemorrhage
  • patients who can not have tDCS (prior head surgery, pacemakers, metallic implants in the head etc)
  • patients taking antiadrenergic medications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01014897

Contacts
Contact: timea hodics, M.D. 214-648-7811 Timea.Hodics@UTSouthwestern.edu

Locations
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Principal Investigator: Timea Hodics, M.D.            
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Timea Hodics, M.D. UTSW
  More Information

No publications provided by University of Texas Southwestern Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Timea Hodics, M.D., Assistant Professor, University of Texas Southwestern
ClinicalTrials.gov Identifier: NCT01014897     History of Changes
Other Study ID Numbers: 032009-067, 032009-067
Study First Received: November 2, 2009
Last Updated: August 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
stroke
recovery
tDCS
direct current
electric stimulation

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 16, 2013