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

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

Study Contact Backup

Study Locations

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.

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

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.

Clinical Trials on TBI (Traumatic Brain Injury)

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