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Electrical 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
University Medicine Greifswald
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Aphasia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 18, 2019
Last Updated
February 6, 2020
Sponsor
University Medicine Greifswald
Collaborators
P.A.N.-Zentrum, Unfallkrankenhaus Berlin, Kliniken Beelitz GmbH
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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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