Treating Traumatic Brain Injury With Transcranial Direct Current Stimulation

NCT06989970 | Not Yet Recruiting

• 1 other identifier: IRB00353047
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Traumatic Brain Injury (TBI) often results in a wide array of cognitive impairments, which can significantly diminish quality of life for affected individuals. While traditional rehabilitation methods typically adopt a standardized approach, it's crucial to acknowledge the significant heterogeneity within the TBI patient population. Neglecting these variations reduces the likelihood of otherwise effective treatments being considered for widespread adoption. Emerging evidence highlights the potential of transcranial direct current stimulation (tDCS) as a promising adjunctive therapy. tDCS, a noninvasive and safe neuro-rehabilitative procedure, has shown efficacy when integrated with cognitive training across various neurological disorders, such as depression, post-stroke aphasia, and neurodegenerative conditions. This study aims to investigate the effectiveness of tDCS paired with behavioral therapy, particularly cognitive training, in improving cognition and executive function in chronic TBI patients. Additionally, tDCs targets in the current study will be tailored to each individual patient, recognizing the patient's unique needs and circumstances

Conditions

Traumatic Brain Injury

Keywords

TBI; Traumatic Brain Injury; Chronic Traumatic Brain Injury; transcranial direct current stimulation; tDCS; Computerized Cognitive Therapy

Outcome Measures

Primary Outcomes (3)

• Change in Selective attention and cognitive flexibility as assessed by the Attention Network Task (ANT)

  This will be measured using the Attention Network Task (ANT). An efficiency score for executive attention is derived by comparing scores on trials with congruent flankers to trials with incongruent flankers. Subjects will tend to be slower and less accurate for incongruent trials, the size of the difference indicates the extent to which an individual can supress conflicting response tendencies. A larger difference between congruent and incongruent trials score indicates a lower executive efficiency (score range: 0-96)..

  Before intervention, immediately after intervention

• Change in attention and task switching as assessed by the N-Back score

  The N-back task is a well-established task that assesses working memory and working memory capacity. Participants are presented with words in sequence and instructed to reply whether the current word matches the one presented 2 words ago (2-back). Scoring will be based on the total number of correct responses (hit rate) minus the number of incorrect responses (false alarm rate), where a greater score is better (score range: 0-80).

  Before intervention, immediately after intervention

• Change in Self-Ordered Pointing Task (SOPT)

  The SOPT is a test used to assess executive functioning. In this task, participants are shown a series of pages, each displaying the same set of abstract images arranged in a random order. On each page, the participant must point to one image, ensuring not to select the same image more than once across the entire series. A correct response involves selecting a previously un-chosen image, while an error is recorded when a participant selects an image already chosen on a previous page. Performance will be measured by total number of errors measured out of the total number of possible responses, with a higher error count indicating greater impairment.

  Before intervention, immediately after intervention

Secondary Outcomes (6)

• Change in attention and task switching as assessed by the Trail Making Task

  Before intervention, immediately after intervention

• Change in Digit Span Forward

  Before intervention, immediately after intervention

• Change in Digit Span Backward

  Before intervention, immediately after intervention

• Change in attention and inhibition as assessed by the Simon Task

  Before intervention, immediately after intervention

• Change in Spatial Span Forward

  Before intervention, immediately after intervention

Other Outcomes (5)

• Change in Global Cognitive Scores as assessed by the Montreal Cognitive Assessment (MoCA)

  Before intervention, immediately after intervention

• Change in verbal fluency task score

  Before intervention, immediately after intervention

• Change in semantic content of connected speech

  Before intervention, immediately after intervention

Study Arms (2)

Active tDCS on the DLPFC + Cognitive Intervention(s) then Sham tDCS

ACTIVE COMPARATOR

Participants will receive left DLPFC active tDCS for 3 weeks, followed by a follow-up immediately after and 2 months later. Active tDCS will be administered for 20 minutes. Cognitive training exercises will be administered concurrently with the tDCS and will take approximately 40 minutes to complete.

Combination Product: Active tDCS on the DLPFC + Cognitive Intervention(s); Combination Product: Sham tDCS on the DLPFC + Cognitive Intervention(s)

Sham tDCS on the DLPFC + Cognitive Intervention(s) then Active tDCS

SHAM COMPARATOR

Participants will receive left DLPFC active tDCS for 3 weeks, followed by a follow-up immediately after and 2 months later. Cognitive training exercises will be administered concurrently with the sham tDCS and will take approximately 40 minutes to complete

Combination Product: Active tDCS on the DLPFC + Cognitive Intervention(s); Combination Product: Sham tDCS on the DLPFC + Cognitive Intervention(s)

Interventions

Active tDCS on the DLPFC + Cognitive Intervention(s) COMBINATION_PRODUCT

Combination Product: Active tDCS and cognitive training intervention. Participants will receive cognitive training paired with active tDCS for 3 weeks, followed by follow-up sessions immediately after and 2 months later, during which the patient's performance on the cognitive training exercises and executive functions will be assessed. Cognitive training exercises have been drawn from a computer-aided cognitive training program (BrainHQ). For the active tDCS, stimulation will be delivered by a battery-driven constant current stimulator. The electrical current will be administered to the left DLPFC at an intensity of 2 milliamperes (mA) (estimated current density 0.04 mA/cm2; estimated total charge 0.048 Coulombs/cm2) in a ramp-like fashion for a maximum of 20 minutes.

Active tDCS on the DLPFC + Cognitive Intervention(s) then Sham tDCS; Sham tDCS on the DLPFC + Cognitive Intervention(s) then Active tDCS

Sham tDCS on the DLPFC + Cognitive Intervention(s) COMBINATION_PRODUCT

Combination Product: Sham tDCS and cognitive training intervention Participants will receive cognitive training paired with sham tDCS for 3 weeks, followed follow-up sessions immediately after and 2 months later, during which the patient's performance on the cognitive training exercises and executive functions will be assessed. Cognitive training exercises have been drawn from a computer-aided cognitive training program (BrainHQ). For the sham tDCS, electrodes will be placed in the same area as in the active tDCS condition, but current will be administered in a ramp-like fashion but after the ramping the intensity will drop to 0 mA. Current under the Sham condition will last for a maximum of 30 seconds.

Active tDCS on the DLPFC + Cognitive Intervention(s) then Sham tDCS; Sham tDCS on the DLPFC + Cognitive Intervention(s) then Active tDCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of traumatic brain injury (TBI) at least 2 years prior to participation
• Right-handed
• English - speaking

You may not qualify if:

• Uncorrected visual impairment
• Uncorrected hearing impairment
• Stroke or other premorbid neurological disorders affecting the brain
• Premorbid learning disorders
• severe claustrophobia
• Cardiac pacemakers, ferromagnetic implants, cochlear implants
• pregnant woman

Sponsors & Collaborators

• Johns Hopkins University: lead
• Ybrain Inc.: collaborator

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Kyrana Tsapkini, PhD.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyrana Tsapkini, PhD.

CONTACT

4107362940; tsapkini@jhmi.edu

Mary Kosmidis, PhD.

CONTACT

mkosmid1@jhu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Both interventions, whether involving tDCS or sham stimulation, will entail a gradual increase in electrical current at the commencement of the stimulation, inducing a transient tingling sensation on the scalp that typically dissipates within seconds. While the ramping process necessitates input from the researcher, it is now feasible to implement blinding procedures for study staff administering tDCS and participants. This is facilitated by a device that enables another team member to designate the setting as "tDCS" or "sham" without the therapist's knowledge. Following the ramping phase, in the sham condition, the intensity of stimulation decreases to 0 mA.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a repeated measures crossover trial, where all participants will receive dorsolateral prefrontal cortex (DLCPFC) stimulation followed by sham stimulation or vice versa. Each condition will be separated by 2 months.

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 25, 2025
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): October 15, 2029
• Study Completion (Estimated): October 15, 2029
• Last Updated: March 25, 2026

Record last verified: 2026-03