Transcranial Direct Current Stimulation (tDCS) in Chronic Stroke Recovery

This study is currently recruiting participants.
Verified December 2013 by University of Texas Southwestern Medical Center
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01014897
First received: November 2, 2009
Last updated: December 11, 2013
Last verified: December 2013
  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

Resource links provided by NLM:


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: September 2014
Estimated Primary Completion Date: September 2014 (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
  • range of motion functional at shoulder elbow wrist and hand

Exclusion Criteria:

  • more than one symptomatic stroke in middle cerebral artery territory or bilateral involvement
  • severe medical or psychiatric conditions, drug abuse, seizure disorder
  • pregnancy/breast feeding
  • subarachnoid hemorrhage, 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: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01014897     History of Changes
Other Study ID Numbers: 032009-067, 032009-067
Study First Received: November 2, 2009
Last Updated: December 11, 2013
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 April 15, 2014