Improvement of Language Disturbances After Stroke by Intensive Training and Electrical Brain Stimulation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by University Hospital Muenster.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00822068
First received: January 13, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted

January 13, 2009
January 13, 2009
January 2009
December 2009   (final data collection date for primary outcome measure)
Number of words correctly named after training plus tDCS [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Communicative-Activity-Log & Stroke-and-Aphasia-Quality-of-Life-Scale [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Improvement of Language Disturbances After Stroke by Intensive Training and Electrical Brain Stimulation
Improvement of Aphasia After Stroke by Intensive Training and Transcranial Direct Current Stimulation

The study aims to identify if intensive language training, consisting mainly of computer-based object naming, together with electrical brain stimulation, will lead to an improvement of language functions in patients that suffer from language disturbances after a stroke.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Aphasia
  • Stroke
  • Device: anodal tDCS
    anodal transcranial direct current stimulation
  • Device: cathodal tDCS
    cathodal transcranial direct current stimulation
  • Device: sham stimulation
    sham stimulation
  • Experimental: anodal tDCS
    Intervention: Device: anodal tDCS
  • Active Comparator: 2
    cathodal tDCS
    Intervention: Device: cathodal tDCS
  • Placebo Comparator: 3
    sham stimulation
    Intervention: Device: sham stimulation
Flöel A, Meinzer M, Kirstein R, Nijhof S, Deppe M, Knecht S, Breitenstein C. Short-term anomia training and electrical brain stimulation. Stroke. 2011 Jul;42(7):2065-7. doi: 10.1161/STROKEAHA.110.609032. Epub 2011 Jun 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • chronic stroke (> 1 year after event)
  • aphasia due to stroke with naming impairment
  • German as first language
  • first-ever stroke

Exclusion Criteria:

  • more than 1 stroke
  • progressive stroke
  • history of severe alcohol or drug abuse, psychiatric illnessess like severe depression, poor motivational capacity
  • dementia
  • contraindications for Magnetic Resonance Imaging
Both
18 Years to 80 Years
No
Contact: Agnes Floel, MD 0049 251 83 ext 45699 floeel@uni-muenster.de
Contact: Caterina Breitenstein, PhD 0049 251 83 ext 49969 breitens@uni-muenster.de
Germany
 
NCT00822068
Aphasia_tDCS
No
Department of Neurology, University of Muenster
University Hospital Muenster
Not Provided
Principal Investigator: Agnes Floel, MD Department of Neurology, University of Muenster; Department of Neurology, University of Berlin, Germany
University Hospital Muenster
January 2009

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