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

NCT06848140 | Recruiting FDA Device

• 2 other identifiers: 2025P0001714R00DC020185-03
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• 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

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

• 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

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

• The Boston Naming Test

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

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

• 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

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

• Rey Auditory Verbal Learning Test and alternative lists

  Evaluation of treatment differences (active versus sham) in change in Rey Auditory Verbal Learning Test. Metric: Number of Total learning items and Correct Recalls.

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

Secondary Outcomes (6)

• The Trail Making Test (Parts A & B)

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

• Digit Span Forward & Backward

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

• Rey-Osterrieth Complex Figure Test

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

• The Digit Symbol Substitution Test

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

• Task-based electroencephalography (EEG) markers during a Go-NoGo task

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

Study Arms (2)

Active to Sham Transcranial direct current stimulation

EXPERIMENTAL

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.

Device: Active Transcranial direct current stimulation; Device: Sham Transcranial direct current stimulation

Sham to Active transcranial direct current stimulation

EXPERIMENTAL

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.

Device: Active Transcranial direct current stimulation; Device: Sham Transcranial direct current stimulation

Interventions

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.

Also known as: tDCS, 1 milliamp tDCS, High definition tDCS, High definition transcranial direct current stimulator, Neuroelectrics Starstim 20 or 32

Active to Sham Transcranial direct current stimulation; Sham to Active transcranial direct current stimulation

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.

Active to Sham Transcranial direct current stimulation; Sham to Active transcranial direct current stimulation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Anomia; Neurobehavioral Manifestations; Brain Injuries

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Language Disorders; Communication Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Hsueh-Sheng Chiang, MD, PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iris Hall, BS

CONTACT

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

Hsueh-Sheng Chiang, MD, PhD

CONTACT

hchiang3@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants, assessors, and technicians interacting with participants will be blind to assigned conditions.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The participants will be randomly assigned to 1 of 2 treatment arms: (1) 1 milliamp transcranial direct current stimulation (tDCS) active treatment applied to pre-supplementary motor area for 20 minutes over 10 sessions to (2) sham tDCS following the same schedule.

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: February 26, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available after publication of primary results or 12 months following study completion, whichever occurs first. The data will be accessible for at least 5 years post-publication.
• Access Criteria: Qualified researchers may request access by submitting a data request with a description of the intended use.

Locations

US (1)