Recruiting

HD-tDCS

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT06848140

Conditions

Traumatic Brain Injury

Word Finding Difficulty

Cognitive Symptom

Cognitive Change

Acquired Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Active Transcranial direct current stimulation

Sham Transcranial direct current stimulation

Study Details

Brief summary:

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.

Conditions

Traumatic Brain Injury

Word Finding Difficulty

Cognitive Symptom

Cognitive Change

Acquired Brain Injury

Study ID

NCT06848140

Start date

Oct 1, 2025

Status verified date

Oct, 2025

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active to Sham Transcranial direct current stimulation

Subjects in this arm will first be randomly assigned to receive active stimulation. After completion of active stimulation, subjects will be assigned to sham stimulation.

experimental: Sham to Active transcranial direct current stimulation

Subjects in this arm will first be randomly assigned to receive sham stimulation. After completion of sham stimulation, subjects will be assigned to active stimulation.

Interventions

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.

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 measure

  • 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. ]
  • 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. ]
  • The Boston Naming Test [ Time Frame: Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. ]
  • 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. ]
  • 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. ]

Central Contacts and Locations

Central contacts

Iris Hall, BS

617-667-0289ihall1@bidmc.harvard.edu

Hsueh-Sheng Chiang, MD, PhD

hchiang3@bidmc.harvard.edu

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Iris Hall, BS

617-667-0289ihall1@bidmc.harvard.edu

Hsueh-Sheng Chiang, MD, PhD

hchiang3@bidmc.harvard.edu

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Oct 21, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2025-10-21.