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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
  Purpose

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.


Condition Intervention Phase
Aphasia
Stroke
 Device: anodal tDCS
Device: cathodal tDCS
Device: sham stimulation
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improvement of Aphasia After Stroke by Intensive Training and Transcranial Direct Current Stimulation

Resource links provided by NLM:

MedlinePlus related topics: Aphasia
U.S. FDA Resources

Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • Number of words correctly named after training plus tDCS [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Communicative-Activity-Log & Stroke-and-Aphasia-Quality-of-Life-Scale [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: January 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: anodal tDCS Device: anodal tDCS
anodal transcranial direct current stimulation
Active Comparator: 2
cathodal tDCS
 Device: cathodal tDCS
cathodal transcranial direct current stimulation
Placebo Comparator: 3
sham stimulation
 Device: sham stimulation
sham stimulation

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00822068

Contacts
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

Locations
Germany
Department of Neurology, University of Muenster; Department of Neurology, University of Berlin Recruiting
Muenster / Berlin, NRW/Berlin-Brandenburg, Germany, 48129/10098
Contact: Agnes Floel, MD     +49 251 83 ext 45699     floeel@uni-muenster.de    
Contact: Caterina Breiteinstein, PhD         breitens@uni-muenster.de    
Principal Investigator: Agnes Floel, MD            
Sponsors and Collaborators
University Hospital Muenster
Investigators
Principal Investigator: Agnes Floel, MD Department of Neurology, University of Muenster; Department of Neurology, University of Berlin, Germany
  More Information

No publications provided by University Hospital Muenster

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

Responsible Party: Department of Neurology, University of Muenster
ClinicalTrials.gov Identifier: NCT00822068     History of Changes
Other Study ID Numbers: Aphasia_tDCS
Study First Received: January 13, 2009
Last Updated: January 13, 2009
Health Authority: Germany: German Board of Psychology

Keywords provided by University Hospital Muenster:
stroke
aphasia
rehabilitation
 transcranial direct current stimulation
intensive training
chronic aphasia after stroke

Additional relevant MeSH terms:
Aphasia
Stroke
Cerebral Infarction
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
 Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 22, 2013