Back to resultsElectrical Stimulation in Traumatic Brain Injury (TBI) Induced Aphasia
Primary Purpose
Aphasia, TBI (Traumatic Brain Injury), tDCS
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
anodal transcranial direct current stimulation (tDCS)- accompanied naming therapy or sham stimulation
Sponsored by
About this trial
This is an interventional other trial for Aphasia
Eligibility Criteria
Inclusion Criteria:
- aphasia assessed by Aachener Aphasie Test (AAT) > 6 month after moderate TBI
- Age: 18 - 80 years
- right handedness
Exclusion Criteria:
- 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
Sites / Locations
- University medicine GreifswaldRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
stimulation group
sham stimulation
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03882502
First Posted
March 18, 2019
Last Updated
February 6, 2020
Sponsor
University Medicine Greifswald
Collaborators
P.A.N.-Zentrum, Unfallkrankenhaus Berlin, Kliniken Beelitz GmbH
1. Study Identification
Unique Protocol Identification Number
NCT03882502
Brief Title
Electrical Stimulation in Traumatic Brain Injury (TBI) Induced Aphasia
Official Title
The Effect of Transcranial Direct Current Stimulation (tDCS) on Naming Ability in Patients With Traumatic Brain Injury Induced Aphasia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
July 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medicine Greifswald
Collaborators
P.A.N.-Zentrum, Unfallkrankenhaus Berlin, Kliniken Beelitz GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, TBI (Traumatic Brain Injury), tDCS
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
stimulation group
Arm Type
Experimental
Arm Title
sham stimulation
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
anodal transcranial direct current stimulation (tDCS)- accompanied naming therapy or sham stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Naming ability assessed by
Description
Performance in a standardised naming task (Boston Naming Task, BNT) under anodal tDCS compared to sham assessed immediately after training period
Time Frame
2 weeks
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:
aphasia assessed by Aachener Aphasie Test (AAT) > 6 month after moderate TBI
Age: 18 - 80 years
right handedness
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Agnes Floeel, Prof
Phone
+49 3834 86 6815
Email
agnes.floeel@uni-greifswald.de
First Name & Middle Initial & Last Name or Official Title & Degree
Katharina Wuesten, PhD
Phone
+49 3834 86 6754
Email
katharina.wuesten@uni-greifswald.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnes Floeel, Prof
Organizational Affiliation
University Medicine Greifswald
Official's Role
Principal Investigator
Facility Information:
Facility Name
University medicine Greifswald
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnes Floeel, Prof
Phone
+49 3834 86 6815
Email
agnes.floeel@uni-greifswald.de
First Name & Middle Initial & Last Name & Degree
Katharina Wuesten, PhD
Phone
+49 3834 86 6754
Email
Katharina.wuesten@uni-greifswald.de
12. IPD Sharing Statement
Learn more about this trial
Electrical Stimulation in Traumatic Brain Injury (TBI) Induced Aphasia
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