High-definition non-invasive brain stimulation for word-finding problems after chronic traumatic brain injury
Using High Definition Transcranial Direct Current Stimulation to Treat Verbal Retrieval Deficits Secondary to Chronic Traumatic Brain Injury (STIM-CTBI)
This trial tries short sessions of non-invasive high-definition transcranial direct current stimulation (HD-tDCS) to see if they help adults with long-term traumatic brain injury who have trouble finding words and remembering things.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06848140 on ClinicalTrials.gov |
What this trial studies
Adults (18–85) with chronic TBI and verified word-finding difficulties are randomized in a double-blind crossover design to receive either active then sham HD-tDCS or sham then active. Each phase consists of 10 sessions over two weeks of 1 mA anodal HD-tDCS targeting the pre-supplementary motor area (preSMA) for 20 minutes, with EEG and cognitive testing at baseline, after the tenth session, and at two-month follow-up; MRI is collected at baseline. Primary outcomes focus on verbal retrieval (fluency, naming, verbal learning), with secondary cognitive and EEG measures. Participants and administering staff are blinded to condition to compare active stimulation to sham.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults aged 18–85 with a non-military chronic TBI (injury >1 year) who have confirmed verbal retrieval difficulties and can attend in-person visits and MRI.
Not a fit: People with recent TBI (<1 year), major active neurologic or psychiatric disorders, current substance use disorder, severe sensory or motor impairments, significant cardiac conditions, or contraindications to brain stimulation or MRI are unlikely to qualify or benefit.
Why it matters
Potential benefit: If successful, this could provide a non-invasive way to improve word-finding and memory in people living with chronic TBI.
How similar studies have performed: Small trials of tDCS for language impairments after stroke or brain injury have shown mixed but sometimes promising results, while rigorous data specifically in chronic TBI remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * Pregnancy
Where this trial is running
Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Hsueh-Sheng Chiang, MD, PhD — Beth Israel Deaconess Medical Center
- Study coordinator: Iris Hall, BS
- Email: ihall1@bidmc.harvard.edu
- Phone: 617-667-0289
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.