Electrical Stimulation in Traumatic Brain Injury (TBI) Induced Aphasia
The Effect of Transcranial Direct Current Stimulation (tDCS) on Naming Ability in Patients With Traumatic Brain Injury Induced Aphasia
1 other identifier
interventional
40
1 country
1
Brief Summary
The aim of this study is to investigate whether a tDCS-accompanied intensive naming therapy leads to a performance improvement in patients with chronic aphasia induced by a moderate TBI
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2019
Typical duration for not_applicable
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
Study Start
First participant enrolled
February 1, 2019
CompletedFirst Submitted
Initial submission to the registry
March 18, 2019
CompletedFirst Posted
Study publicly available on registry
March 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedFebruary 7, 2020
February 1, 2020
1.5 years
March 18, 2019
February 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Naming ability assessed by
Performance in a standardised naming task (Boston Naming Task, BNT) under anodal tDCS compared to sham assessed immediately after training period
2 weeks
Study Arms (2)
stimulation group
EXPERIMENTALsham stimulation
SHAM COMPARATORInterventions
anodal tDCS or sham stimulation will be combined with an intensive naming training and the number of items that could be named will be assessed immediately after the intervention.
Eligibility Criteria
You may qualify if:
- aphasia assessed by Aachener Aphasie Test (AAT) \> 6 month after moderate TBI
- Age: 18 - 80 years
- right handedness
You may not qualify if:
- dementia or other neurological diseases
- History of severe alcoholism or use of drugs
- Severe psychiatric disorders such as depression, psychosis (if not in remission)
- Severe untreated medical problems such as cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Medicine Greifswaldlead
- P.A.N.-Zentrumcollaborator
- Unfallkrankenhaus Berlincollaborator
- Kliniken Beelitz GmbHcollaborator
Study Sites (1)
University medicine Greifswald
Greifswald, 17475, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Agnes Floeel, Prof
University Medicine Greifswald
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2019
First Posted
March 20, 2019
Study Start
February 1, 2019
Primary Completion
July 31, 2020
Study Completion
December 31, 2020
Last Updated
February 7, 2020
Record last verified: 2020-02