- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03882502
Electrical Stimulation in Traumatic Brain Injury (TBI) Induced Aphasia
February 6, 2020 updated by: University Medicine Greifswald
The Effect of Transcranial Direct Current Stimulation (tDCS) on Naming Ability in Patients With Traumatic Brain Injury Induced Aphasia
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
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Agnes Floeel, Prof
- Phone Number: +49 3834 86 6815
- Email: agnes.floeel@uni-greifswald.de
Study Contact Backup
- Name: Katharina Wuesten, PhD
- Phone Number: +49 3834 86 6754
- Email: Katharina.wuesten@uni-greifswald.de
Study Locations
-
-
-
Greifswald, Germany, 17475
- Recruiting
- University Medicine Greifswald
-
Contact:
- Agnes Floeel, Prof
- Phone Number: +49 3834 86 6815
- Email: agnes.floeel@uni-greifswald.de
-
Contact:
- Katharina Wuesten, PhD
- Phone Number: +49 3834 86 6754
- Email: Katharina.wuesten@uni-greifswald.de
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: stimulation group
|
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.
|
SHAM_COMPARATOR: sham stimulation
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Naming ability assessed by
Time Frame: 2 weeks
|
Performance in a standardised naming task (Boston Naming Task, BNT) under anodal tDCS compared to sham assessed immediately after training period
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Agnes Floeel, Prof, University Medicine Greifswald
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 1, 2019
Primary Completion (ANTICIPATED)
July 31, 2020
Study Completion (ANTICIPATED)
December 31, 2020
Study Registration Dates
First Submitted
March 18, 2019
First Submitted That Met QC Criteria
March 18, 2019
First Posted (ACTUAL)
March 20, 2019
Study Record Updates
Last Update Posted (ACTUAL)
February 7, 2020
Last Update Submitted That Met QC Criteria
February 6, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Craniocerebral Trauma
- Trauma, Nervous System
- Language Disorders
- Communication Disorders
- Speech Disorders
- Brain Injuries
- Wounds and Injuries
- Brain Injuries, Traumatic
- Aphasia
Other Study ID Numbers
- BISCUIT Trial 2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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