NCT06848140 · Beth Israel Deaconess Medical Center
Using Non-invasive Brain Stimulation to Treat Word Finding Difficulty in Chronic Traumatic Brain Injury
(STIM-CTBI)
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Active Transcranial direct current stimulation
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.
DEVICE
Sham Transcranial direct current stimulation
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.
Primary outcome measures
The Controlled Oral Word Association Test - letter fluency
Time frame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
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
Time frame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Evaluation of treatment differences (active versus sham) in change on Category Fluency. Metric: Number of Correct Items Generated
The Boston Naming Test
Time frame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
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
Time frame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Evaluation of treatment differences (active versus sham) in change on the Delis Kaplan Color Word Interference Test. Metric: Time to Name Items
Rey Auditory Verbal Learning Test and alternative lists
Time frame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment.
Evaluation of treatment differences (active versus sham) in change in Rey Auditory Verbal Learning Test. Metric: Number of Total learning items and Correct Recalls.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- Has a confirmation of verbal retrieval difficulties as measured by the Verbal Retrieval Difficulty Interview questions
Exclusion criteria
- 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)
- Severe depression at the time of enrollment (BDI-II \>= 29) or psychiatric ER visits or hospitalization less than 6 months ago prior to enrollment
- Current sensory (e.g., blind, deaf) or physical (e.g., severe motor weakness) impairment that interferes with testing
- Contraindications for tDCS or MRI
- The person cannot be left alone for 8+ hours.
- Not verbally communicative.
- Currently undergoing and not wishing to discontinue speech and cognitive therapy during study participation.
- Incapable of understanding the consent or unable to consent for oneself.
- Unable to travel to BIDMC's Berenson-Allen Center
Where
- Boston, Massachusetts
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 21, 2025 · Source of record for eligibility and locations