About this trial
The purpose of this study is to learn more about how brain stimulation affects word finding problems in people who have a traumatic brain injury (TBI). The type of brain stimulation used is called transcranial direct current stimulation (tDCS). tDCS delivers low levels of electric current to the brain and high definition tDCS (HD-tDCS) delivers the current with multiple electrodes on the scalp. This current is delivered with HD-tDCS to parts of the brain that may help with remembering things. The investigators hope that this can help to improve word finding and memory problems in people with TBI.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 85
Fluent in speaking and reading English
Able to provide informed consent
Has a TBI at least one year prior to enrollment and not related to military experience
Disqualifiers
Lifetime major or active neurologic conditions (e.g., stroke, epilepsy, brain tumor, dementia, seizure occurrence less than one year ago)
Lifetime major or active cardiovascular conditions (e.g., cardiac arrythmia, heart failure, heart attack)
Current substance use disorder
Lifetime major psychiatric disorders (e.g., schizophrenia, bipolar disorder)
Trial design
Crossover
Treatments tested in this trial
Active Transcranial direct current stimulation
DeviceTranscranial direct current stimulation will be delivered via a Neuroelectrics Starstim 20 or 32. Stimulation will consist of 1 milliamp stimulation, with anodal stimulation delivered at electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, then remain at 1 milliamp of stimulation over 20 minutes, and finally ramping down at to 0 milliamps over 60 seconds.
Sham Transcranial direct current stimulation
DeviceSham transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim 20 or 32. The sham setup will consist of anodal electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, ramp down to 0 milliamps over 60 seconds and then be left off for 20 minutes.
Treatment groups
Trial outcomes
Primary outcomes
The Controlled Oral Word Association Test - letter fluency
Evaluation of treatment differences (active versus sham) in change on the Control Word Association Test. Metric: Number of Correct Items Generated
The Controlled Oral Word Association Test - category fluency
Evaluation of treatment differences (active versus sham) in change on Category Fluency. Metric: Number of Correct Items Generated
The Boston Naming Test
Evaluation of treatment differences (active versus sham) in change on The Boston Naming Test. Metric: Number of Correct Items Generated.
The Delis Kaplan Color Word Interference Test
Evaluation of treatment differences (active versus sham) in change on the Delis Kaplan Color Word Interference Test. Metric: Time to Name Items
Secondary outcomes
The Trail Making Test (Parts A & B)
Evaluation of treatment differences (active versus sham) in change on the Trail Making Test (Parts A\&B). Metric: Time to Solution
Digit Span Forward & Backward
Evaluation of treatment differences (active versus sham) in change in Digit Span Forward \& Backward. Metric: Memory Span
Rey-Osterrieth Complex Figure Test
Evaluation of treatment differences (active versus sham) in change in Rey-Osterrieth Complex Figure Test scores. Metric: Score
The Digit Symbol Substitution Test
Evaluation of treatment differences (active versus sham) in change on the Digit Symbol Substitution Test. Metric: Number of Items
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Beth Israel Deaconess Medical Center
Lead sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator