Electrical Stimulation in Traumatic Brain Injury (TBI) Induced Aphasia

Aphasia Clinical Trial

Official title:

The Effect of Transcranial Direct Current Stimulation (tDCS) on Naming Ability in Patients With Traumatic Brain Injury Induced Aphasia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03882502
• Other study ID #: BISCUIT Trial 2019
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2020
• Source: University Medicine Greifswald
• Contact: Agnes Floeel, Prof
• Phone: +49 3834 86 6815
• Email: agnes.floeel[@]uni-greifswald.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aphasia
• Brain Injuries
• Brain Injuries, Traumatic
• TBI (Traumatic Brain Injury)
• tDCS
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Germany	University medicine Greifswald	Greifswald

Sponsors (4)

Lead Sponsor	Collaborator
University Medicine Greifswald	Kliniken Beelitz GmbH, P.A.N.-Zentrum, Unfallkrankenhaus Berlin

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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