Transcranial Direct Current Stimulation (tDCS) in Chronic Stroke Recovery

This study is currently recruiting participants. (see Contacts and Locations)
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
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: 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 July 31, 2014