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Electrical Stimulation in Traumatic Brain Injury (TBI) Induced Aphasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03882502
Recruitment Status : Unknown
Verified February 2020 by University Medicine Greifswald.
Recruitment status was:  Recruiting
First Posted : March 20, 2019
Last Update Posted : February 7, 2020
Sponsor:
Collaborators:
P.A.N.-Zentrum
Unfallkrankenhaus Berlin
Kliniken Beelitz GmbH
Information provided by (Responsible Party):
University Medicine Greifswald

Study Description
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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

Condition or disease Intervention/treatment Phase
Aphasia TBI (Traumatic Brain Injury) tDCS Other: anodal transcranial direct current stimulation (tDCS)- accompanied naming therapy or sham stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: The Effect of Transcranial Direct Current Stimulation (tDCS) on Naming Ability in Patients With Traumatic Brain Injury Induced Aphasia
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: stimulation group Other: anodal transcranial direct current stimulation (tDCS)- accompanied naming therapy or 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.
Sham Comparator: sham stimulation Other: anodal transcranial direct current stimulation (tDCS)- accompanied naming therapy or 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03882502


Contacts
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Contact: Agnes Floeel, Prof +49 3834 86 6815 agnes.floeel@uni-greifswald.de
Contact: Katharina Wuesten, PhD +49 3834 86 6754 katharina.wuesten@uni-greifswald.de

Locations
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Germany
University medicine Greifswald Recruiting
Greifswald, Germany, 17475
Contact: Agnes Floeel, Prof    +49 3834 86 6815    agnes.floeel@uni-greifswald.de   
Contact: Katharina Wuesten, PhD    +49 3834 86 6754    Katharina.wuesten@uni-greifswald.de   
Sponsors and Collaborators
University Medicine Greifswald
P.A.N.-Zentrum
Unfallkrankenhaus Berlin
Kliniken Beelitz GmbH
Investigators
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Principal Investigator: Agnes Floeel, Prof University Medicine Greifswald
More Information
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Responsible Party: University Medicine Greifswald
ClinicalTrials.gov Identifier: NCT03882502    
Other Study ID Numbers: BISCUIT Trial 2019
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Aphasia
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations