Chronic Aphasia - Improved by Intensive Training and Electrical Brain Stimulation
CATS
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study is to determine if non-invasive electrical brain stimulation can enhance the out of intensive language therapy in chronic aphasia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2011
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2010
CompletedFirst Posted
Study publicly available on registry
October 15, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedAugust 27, 2013
August 1, 2013
3.6 years
October 13, 2010
August 26, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Boston Naming Test
Change of naming score from baseline (day 1 of study) to immediately after 2-week intervention period (post-testing)
Secondary Outcomes (3)
Boston Naming Test
Change of naming score from post-testing (after end of intervention) to 3 months after the intervention (follow-up)
Naming performance during functional magnetic resonance scanning
Change of naming score from baseline (day 1 of study) to immediately after 2-week intervention period (post-testing)
Naming performance during functional magnetic resonance imaging
Change of naming score from post-testing (after end of intervention) to 3 months after the intervention (follow-up)
Study Arms (2)
sham tDCS
PLACEBO COMPARATORanodal tDCS
EXPERIMENTALInterventions
2 weeks of daily computerized naming training, daily, 3 hours
Eligibility Criteria
You may qualify if:
- right-handedness
- single first time left-hemisphere stroke
- fluent- or non-fluent chronic aphasia (more than six months post-stroke)
- anomia (PR\>10 and PR\<60 Aachen Aphasia Naming Subtest)
- native German Speaker
You may not qualify if:
- more than one stroke
- alcoholism, severe psychiatric conditions, other neurological conditions
- other non-treated medical problems, severe microangiopathy
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Charite, University Medicine, Dept. of Neurology
Berlin, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcus Meinzer, PhD
Charite, University Medicine, Neurology
- STUDY DIRECTOR
Agnes Flöel, MD
Charite, University Medicine, Neurology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Creutzfeldt Fellow
Study Record Dates
First Submitted
October 13, 2010
First Posted
October 15, 2010
Study Start
January 1, 2011
Primary Completion
August 1, 2014
Study Completion
December 1, 2014
Last Updated
August 27, 2013
Record last verified: 2013-08