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

Stroke Clinical Trial

Official title:

Improvement of Aphasia After Stroke by Intensive Training and Transcranial Direct Current Stimulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00822068
• Other study ID #: Aphasia_tDCS
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: January 13, 2009
• Last updated: January 13, 2009
• Start date: January 2009
• Est. completion date: December 2009

Study information

• Verified date: January 2009
• Source: University Hospital Muenster
• Contact: Agnes Floel, MD
• Phone: 0049 251 83
• Email: floeel[@]uni-muenster.de
• Is FDA regulated: No
• Health authority: Germany: German Board of Psychology
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aphasia
• Stroke

Intervention

Device:
• anodal tDCS
anodal transcranial direct current stimulation
• cathodal tDCS
cathodal transcranial direct current stimulation
• sham stimulation
sham stimulation

Locations

Country	Name	City	State
Germany	Department of Neurology, University of Muenster; Department of Neurology, University of Berlin	Muenster / Berlin	NRW/Berlin-Brandenburg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of words correctly named after training plus tDCS		1 year	No
Secondary	Communicative-Activity-Log & Stroke-and-Aphasia-Quality-of-Life-Scale		1 year	Yes