Back to resultsImprovement of Language Disturbances After Stroke by Intensive Training and Electrical Brain Stimulation
Primary Purpose
Aphasia, Stroke
Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
anodal tDCS
cathodal tDCS
sham stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Aphasia focused on measuring stroke, aphasia, rehabilitation, transcranial direct current stimulation, intensive training, chronic aphasia after stroke
Eligibility 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
Sites / Locations
- Department of Neurology, University of Muenster; Department of Neurology, University of BerlinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
anodal tDCS
2
3
Arm Description
cathodal tDCS
sham stimulation
Outcomes
Primary Outcome Measures
Number of words correctly named after training plus tDCS
Secondary Outcome Measures
Communicative-Activity-Log & Stroke-and-Aphasia-Quality-of-Life-Scale
Full Information
NCT ID
NCT00822068
First Posted
January 13, 2009
Last Updated
January 13, 2009
Sponsor
University Hospital Muenster
1. Study Identification
Unique Protocol Identification Number
NCT00822068
Brief Title
Improvement of Language Disturbances After Stroke by Intensive Training and Electrical Brain Stimulation
Official Title
Improvement of Aphasia After Stroke by Intensive Training and Transcranial Direct Current Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital Muenster
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Stroke
Keywords
stroke, aphasia, rehabilitation, transcranial direct current stimulation, intensive training, chronic aphasia after stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
anodal tDCS
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Arm Description
cathodal tDCS
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
sham stimulation
Intervention Type
Device
Intervention Name(s)
anodal tDCS
Intervention Description
anodal transcranial direct current stimulation
Intervention Type
Device
Intervention Name(s)
cathodal tDCS
Intervention Description
cathodal transcranial direct current stimulation
Intervention Type
Device
Intervention Name(s)
sham stimulation
Intervention Description
sham stimulation
Primary Outcome Measure Information:
Title
Number of words correctly named after training plus tDCS
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Communicative-Activity-Log & Stroke-and-Aphasia-Quality-of-Life-Scale
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Agnes Floel, MD
Phone
0049 251 83
Ext
45699
Email
floeel@uni-muenster.de
First Name & Middle Initial & Last Name or Official Title & Degree
Caterina Breitenstein, PhD
Phone
0049 251 83
Ext
49969
Email
breitens@uni-muenster.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnes Floel, MD
Organizational Affiliation
Department of Neurology, University of Muenster; Department of Neurology, University of Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology, University of Muenster; Department of Neurology, University of Berlin
City
Muenster / Berlin
State/Province
NRW/Berlin-Brandenburg
ZIP/Postal Code
48129/10098
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnes Floel, MD
Phone
+49 251 83
Ext
45699
Email
floeel@uni-muenster.de
First Name & Middle Initial & Last Name & Degree
Caterina Breiteinstein, PhD
Email
breitens@uni-muenster.de
First Name & Middle Initial & Last Name & Degree
Agnes Floel, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
21636820
Citation
Floel 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.
Results Reference
derived
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Improvement of Language Disturbances After Stroke by Intensive Training and Electrical Brain Stimulation
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