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

November 2, 2009
December 11, 2013
April 2009
September 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01014897 on ClinicalTrials.gov Archive Site
adverse events [ Time Frame: immediately before and immediately after treatment ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Transcranial Direct Current Stimulation (tDCS) in Chronic Stroke Recovery
tDCS in Chronic Stroke Recovery-pilot

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

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Stroke
Device: tDCS
tDCS and sham will be applied in random order during standardized occupational therapy
Other Name: transcranial direct current stimulation
  • Experimental: subcortical
    Subcortical stroke patients will receive tDCS stimulation and sham in random order
    Intervention: Device: tDCS
  • Experimental: cortical
    subjects will receive active and sham tDCS in random order
    Intervention: Device: tDCS
Hodics TM, Nakatsuka K, Upreti B, Alex A, Smith PS, Pezzullo JC. Wolf Motor Function Test for characterizing moderate to severe hemiparesis in stroke patients. Arch Phys Med Rehabil. 2012 Nov;93(11):1963-7. doi: 10.1016/j.apmr.2012.05.002. Epub 2012 May 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
September 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: timea hodics, M.D. 214-648-7811 Timea.Hodics@UTSouthwestern.edu
United States
 
NCT01014897
032009-067, 032009-067
No
University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
Not Provided
Principal Investigator: Timea Hodics, M.D. UTSW
University of Texas Southwestern Medical Center
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP