Using Non-invasive Brain Stimulation to Treat Word Finding Difficulty in Chronic Traumatic Brain Injury

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorBeth Israel Deaconess Medical Center

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • Active Transcranial direct current stimulation

    Device

    Transcranial 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

    Device

    Sham 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

24 Participants
are divided into 2 treatment groups
Group A: Active to Sham Transcranial direct current stimulationExperimental treatment 2 interventions
Group B: Sham to Active transcranial direct current stimulationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
2

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

Time frame
Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
3

The Boston Naming Test

Evaluation of treatment differences (active versus sham) in change on The Boston Naming Test. Metric: Number of Correct Items Generated.

Time frame
Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
4

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

Time frame
Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.

Secondary outcomes

1

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

Time frame
Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
2

Digit Span Forward & Backward

Evaluation of treatment differences (active versus sham) in change in Digit Span Forward \& Backward. Metric: Memory Span

Time frame
Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
3

Rey-Osterrieth Complex Figure Test

Evaluation of treatment differences (active versus sham) in change in Rey-Osterrieth Complex Figure Test scores. Metric: Score

Time frame
Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
4

The Digit Symbol Substitution Test

Evaluation of treatment differences (active versus sham) in change on the Digit Symbol Substitution Test. Metric: Number of Items

Time frame
Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.

Other outcomes

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