High-definition non-invasive brain stimulation for word-finding problems after chronic traumatic brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.