Remotely Supervised tDCS+ for Complex Attention in mTBI (Cognetric)

NCT06413173 | Recruiting

• 1 other identifier: NMCSD.2023.0048
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

Brief Summary

The proposed study will evaluate a new approach to cognitive rehabilitation of mTBI using a brain stimulation technique called "Remotely Supervised Transcranial Direct Current Stimulation combined with Cognitive Training" (RS-tDCS+) which has shown promise for improving complex attention in both healthy and clinical populations. RS-tDCS+ is a home-based, low-risk, non-invasive technique that is designed to boost cognitive training by enhancing learning and the brain's ability to reorganize connections. This study will evaluate RS-tDCS+ for improving complex attention in Active Duty Service Members (ADSM) and Veterans with a history of mTBI. Different tests of complex attention and symptom questionnaires will be used to determine the effects of real versus sham (placebo) RS-tDCS+. Second, the investigators will investigate electrical and connectivity changes in the brain associated with RS-tDCS+ using electroencephalogram (EEG) and magnetic resonance imaging (MRI). Third, the investigators will investigate the lasting effects of any observed changes by evaluating participants at 1 and 6 weeks post-treatment. Lastly, the investigators will explore the impact of individual differences (e.g., PTSD, depression, sleep quality, time since injury, baseline impairment, age, sex, ADSM versus Veteran) on treatment outcome.

Conditions

Brain Concussion; Brain Trauma; Attention Concentration Difficulty; Brain Injuries; Brain Injuries, Traumatic; Neurocognitive Dysfunction; Attention Impaired; Memory Impairment; Mild Traumatic Brain Injury; Mild Cognitive Impairment; Post Concussive Symptoms

Keywords

Military Health; Brain Stimulation; Cognitive Training; Cognitive Rehabilitation; Telehealth; Neuromodulation

Outcome Measures

Primary Outcomes (22)

• Symbol Digit Modalities Test (SDMT)

  Standardized neuropsychological assessment measure of visual attention and working memory

  Baseline, 1-week post, & 6-weeks post intervention

• Neuropsychological Assessment Battery (NAB) Attention Module

  Standardized neuropsychological assessment consisting of 4 subtests to assess visual and auditory attention, working memory, and scanning

  Baseline, 1-week post, & 6-weeks post intervention

• Neurobehavioral Symptom Inventory (NSI)

  A measure of common post-concussive symptoms rated on a 5-point Likert scale (0-4); with low scores corresponding to mild or no incidence of symptoms and high scores corresponding to more severe incidence of symptoms.

  Baseline, 1-week post, & 6-weeks post intervention

• Electroencephalogram (EEG) - Resting State Functional Connectivity

  Resting State EEG will be collected to assess neural dynamics or functional connectivity and spectral power of delta,theta, alpha, beta, and gamma frequency bands.

  Baseline, 1-week post, & 6-weeks post intervention

• Electroencephalogram (EEG) - Resting State Spectral Power

  Resting State EEG will be collected to assess spectral power of standard frequency bands (delta, theta, alpha, beta, and gamma).

  Baseline, 1-week post, & 6-weeks post intervention

• Magnetic Resonance Imaging (MRI) - T1 (optional)

  MRI will be used to collect a T1-weighted (structural scan) pulse sequence of the brain.

  Baseline & 1-week post intervention

• Magnetic Resonance Imaging (MRI) - T2 (optional)

  MRI will be used to collect a T2-weighted pulse sequence of the brain.

  Baseline & 1-week post intervention

• Magnetic Resonance Imaging (MRI) - T2* (optional)

  MRI will be used to collect a T2\*-weighted (BOLD-contrast fMRI / Resting State) pulse sequence of the brain.

  Baseline & 1-week post intervention

• Magnetic Resonance Imaging (MRI) - DWI (optional)

  MRI will be used to collect a Diffusion Weighted Imaging (DWI) pulse sequence of the brain (white-matter tractography).

  Baseline & 1-week post intervention

• Magnetic Resonance Imaging (MRI) - ASL (optional)

  MRI will be used to collect an Arterial Spin Labeling (ASL / Blood Flow Rate) pulse sequence of the brain.

  Baseline & 1-week post intervention

• Magnetic Resonance Imaging (MRI) - ROI Analysis (optional)

  T2\*-weighted (Resting State) images will be analyzed with Region of Interest (ROI) time-courses to generate a partial correlation value (Fisher Z) that depicts functional connectivity.

  Baseline & 1-week post intervention

• NIH Toolbox Quality of Life Assessment (NeuroQoL)

  Questionnaire to assess quality of life with regard to cognitive, social, emotional, and behavioral abilities rated on a 5-point Likert scale (1-5); with low scores corresponding to mild to no impairment in these abilities and high scores corresponding to more severe impairment in these abilities.

  Baseline, 1-week post, & 6-weeks post intervention

• Insomnia Severity Index (ISI)

  Measure of insomnia severity rated on a 5-point Likert scale (0-4); with low scores corresponding to mild or no incidence of insomnia and high scores corresponding to more severe incidences of insomnia.

  Baseline, 1-week post, & 6-weeks post intervention

• Patient Health Questionnaire (PHQ-8)

  The PHQ is a self-report inventory that is used as a screening and diagnostic tool for depressive disorders using a 4-point Likert scale (e.g., 0 = not at all, 3 = nearly every day), yielding a total score from 0 - 21. The eight-item Patient Health Questionnaire depression scale (PHQ-8) is established as a valid diagnostic and severity measure for depressive disorders in large clinical research studies.

  Baseline, 1-week post, & 6-weeks post intervention

• PTSD Checklist- Civilian Version (PCL-C)

  A 17-item self-report rating scale used as a screening tool for posttraumatic stress disorder (PTSD) using a 5-point Likert scale (e.g., 1 = not at all, 5 = extremely), yielding a total score from 17 - 85. This version asks about symptoms in relation to generic "stressful experiences" and can be used with any population. It simplifies assessment based on multiple traumas because symptom endorsements are not attributed to a specific event. Importantly, the PCL-C has been established as a valid measure of PTSD severity in Active Duty Service Members and Veterans.

  Baseline, 1-week post, & 6-weeks post intervention

• Patient Global Impression of Change (PGIC)

  This scale evaluates all aspects of patients' health and assesses if there has been an improvement or decline in clinical status. Specifically, individuals are asked to calculate the difference between their current and previous health state based on a Likert scale. They are required to answer the question "Since beginning treatment at this clinic, how would you describe the change (if any) in activity limitations, symptoms, emotions, and overall quality of life, related to your painful condition." Score ranges from 1 (no change or condition got worse) to 7 (a great deal better). They are then required to circle a number between 0 to 10 that reflects the degree of change since the start of the intervention. The test takes approximately 2 minutes to complete.

  1-week post & 6-weeks post intervention

• Information Sampling Task (IST)

  A test of reflection impulsivity. It presents a series of trials with an array of 25 grey boxes arranged in a 5x5 matrix. The grey boxes conceal yellow or blue squares on each trial. The subject decides which of the two underlying colors (yellow or blue) lay in the majority. The subject can open as many boxes as they wish to make a decision. Correct decisions are awarded a number of points.

  Baseline, 1-week post, & 6-weeks post intervention

• Groton Maze Learning Task (GMLT)

  A cognitive test of spatial working memory and error monitoring that has been shown to be sensitive to detecting longitudinal change in cognitive ability.78 It consists of a 10 x 10 grid of grey tiles. To complete the maze, the participant must click on the tiles to follow a hidden pathway through the grid from the top left corner to the bottom right corner. They must only click on adjacent tiles, and return to the previous tile if an error is made before moving on. The participant receives visual and auditory feedback for correct and incorrect moves. There are various types of errors (e.g., perseverative error, rule-break error) recorded depending on which type of rule has been broken, and the time to complete the maze is recorded. The trial ends once the participant reaches the bottom right corner of the grid of tiles.

  Baseline, 1-week post, & 6-weeks post intervention

• Fusion Task: BEAM

  For the BEAM subtask, the subject will be directed to change his/her fixation from a crosshair displayed at the center of screen to a white circle appearing randomly on the left or right side of the screen. The subject will press a button labeled either "Left" or "Right" based on whether the circle appeared on the left or right of the screen. In a small percentage of the trials in which a red arrow appears in the center of the screen, the subject will be instructed not to look at the circle nor press any buttons (inhibition test). Saccadic eye movements, pupil responses, and manual response time (RT) in addition to errors will be recorded.

  Baseline, 1-week post, & 6-weeks post intervention

• Fusion Task: N-Back

  For the N-Back subtask, the subject will be directed to change his/her fixation from a cross sign displayed at the center of screen to a colored circle (Green or Blue) that randomly appears on the left or right side of the screen. In the first, '0-back' condition, the subject shall push a response button labeled either (1) "GREEN" or (2) "BLUE" in accordance with the color of the circle currently on the screen. In the second, '1-back' condition, immediately upon recognition of the color of the circle, the subject shall push a response button labeled with either (1) "SAME" if the color matches the circle that appeared previously, or (2) "DIFFERENT" if the color does not match. Saccadic eye movements, pupil responses, and manual response time (RT) in addition to errors will be recorded.

  Baseline, 1-week post, & 6-weeks post intervention

• tDCS Symptom Rating Questionnaire (SRQ)

  Questionnaire to assess pre-post tDCS symptom rating, rated on a 4-point Likert scale (0-3); with low scores corresponding to mild or no incidence of symptoms and high scores corresponding to severe incidence of symptoms.

  Assessment collected daily during the intervention block (b/t baseline & 1-week post)

• Ecological Momentary Assessment (EMA)

  A data capture technique that involves repeated sampling of thoughts, feelings, or behaviors as close in time to the experience as possible in the naturalistic environment. A series of 18 self-report questions rated on a 10-point Likert scale (Q1 - Q15) and 5-point Likert scale (Q16 - Q18) regarding mood, current cognitive state, and environment. EMA data is used to look for relationships between variables with the causal discovery analysis.

  Assessment collected daily during the intervention block (b/t baseline & 1-week post)

Secondary Outcomes (2)

• BrainHQ Task Load Index (TLX)

  Collected during the Intervention block at sessions 1, 5, & 10 (b/t baseline & 1-week post)

• Fusion Task Load Index (F-TLX)

  Baseline, 1-week post, & 6-weeks post intervention

Study Arms (2)

Active tDCS

EXPERIMENTAL

Participants will receive 10 sessions of cognitive training concurrent with transcranial direct current stimulation. Stimulation will be applied for 20 minutes at the beginning of each session. Current will be ramped from 0 mA to 2 mA over 30 seconds, and then ramped down from 2 mA to 0 mA at the end of 20 minutes. Current will be applied via two electrodes consisting of a pre-inserted carbon rubber snap electrode that is pre-saturated with saline and connects directly to designated electrode sites located on the tDCS headband. The anodal stimulating electrode will be at location F3 (based on the 10-20 EEG location system) and the cathodal electrode at location F4.

Combination Product: Active tDCS and Cognitive Training Intervention

Sham tDCS

SHAM COMPARATOR

Electrodes will be placed at the same positions as for active stimulation (F3 and F4), but current will be ramped down immediately after the initial 30s ramp up period and then at 20 minutes ramped up and down as done at the beginning. Thus, participants feel the initial tingling sensation associated with tDCS, but will receive no active current for the rest of the stimulation period

Combination Product: Sham tDCS and Cognitive Training Intervention

Interventions

Active tDCS and Cognitive Training Intervention COMBINATION_PRODUCT

Cognitive training will occur concurrently with active tDCS session. The cognitive training occurs on a computer and consists of 5 exercises specifically selected and scientifically supported to (i) place demands on the executive function system (e.g. working memory, behavioral inhibition, decision making, and set- shifting), (ii) adapt to challenge the participant's current ability level, (iii) provide ongoing feedback, and (iv) present novel stimuli across visual and auditory modalities During each 45-minute training period, participants will complete the daily assigned adaptive training module. Following the completion of training sessions 1, 5, and 10, participants will be asked to supply a subjective workload assessment.

Active tDCS

Sham tDCS and Cognitive Training Intervention COMBINATION_PRODUCT

Cognitive training will occur concurrently with sham tDCS session. The cognitive training occurs on a computer and consists of 5 exercises specifically selected and scientifically supported to (i) place demands on the executive function system (e.g. working memory, behavioral inhibition, decision making, and set- shifting), (ii) adapt to challenge the participant's current ability level, (iii) provide ongoing feedback, and (iv) present novel stimuli across visual and auditory modalities During each 45-minute training period, participants will complete the daily assigned adaptive training module. Following the completion of training sessions 1, 5, and 10, participants will be asked to supply a subjective workload assessment.

Sham tDCS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Active-Duty Service Members.
• Ages 18 to 60.
• All genders.
• All racial and ethnic groups.
• History of mild TBI (as defined by the DOD/VA criteria used in conjunction with the OSU TBI-ID) sustained at least 3 months and no more than 10 years prior to enrollment.
• Self-reported attention and/or concentration difficulties.
• At least one cognitive symptom reported on the Neurobehavioral Symptom Inventory (NSI) cognitive subscale.

You may not qualify if:

• Presence of a medical, psychiatric, physical or non-physical disease, disorder, condition, injury, disability or pre-existent history such that study participation, in the opinion of the PI: (a) may pose a significant risk to the participant; (b) raises the possibility that the participant is unlikely to successfully complete all of the requirements of the study according to the study protocol; or (c) might adversely impact the integrity of the data or the validity of the study results. Specific conditions include (but are not limited to) a history of: brain tumor, epilepsy, cerebral vascular accident (CVA), Schizophrenia, Bipolar Disorder, and Mania.
• History of prior treatment with ECT or neuromodulation in the last 12 months.
• Current, diagnosed substance dependence.
• Newly prescribed medication within the previous 3 weeks.
• Diagnosis of intellectual disability or pervasive developmental disorder (i.e., premorbid IQ less than or equal to 70).
• Any medical condition or treatment other than mild TBI (e.g., stroke, tumor, HIV, moderate-severe TBI), with significant neurological disorder or insults that, based on the Principal Investigator's judgment, would impact risk.
• Psychosis or mania within 30 days of enrollment, as determined by the PI, based on a psychiatric history and examination and/or a review of available medical records
• Contraindications for tDCS (e.g., metallic cranial plates/screws or implanted device, eczema or skin lesions on scalp)
• A positive pregnancy report.

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead
• Minneapolis Veterans Affairs Medical Center: collaborator
• University of Minnesota: collaborator
• United States Department of Defense: collaborator
• Center for Veterans Research and Education: collaborator
• The Defense and Veterans Brain Injury Center: collaborator
• General Dynamics Information Technology: collaborator

Study Sites (2)

Naval Medical Center San Diego

San Diego, California, 92134, United States

RECRUITING

Minneapolis VA Health Case System

Minneapolis, Minnesota, 55417, United States

RECRUITING

MeSH Terms

Conditions

Brain Concussion; Brain Injuries, Traumatic; Brain Injuries; Cognition Disorders; Memory Disorders; Cognitive Dysfunction; Post-Concussion Syndrome

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lars D Hungerford, PhD

  United States Naval Medical Center, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars D Hungerford, PhD

CONTACT

619.532.5715; lars.d.hungerford.ctr@health.mil

Sean M Molnar, M.A.

CONTACT

424.341.8860; sean.m.molnar2.ctr@health.mil

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The tDCS unit software has a double-blind selection, blinding all study members, care providers, and participants until blinds are broken.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinical Research Director

Model Details: This is a double-blind, randomized, placebo (sham) controlled pilot study.

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 14, 2024
• Study Start: July 25, 2024
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)