Recruiting

tDCS+

Sponsor:

United States Naval Medical Center, San Diego

Code:

NCT06413173

Conditions

Brain Concussion

Brain Trauma

Attention Concentration Difficulty

Brain Injuries

Brain Injuries, Traumatic

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Active tDCS and Cognitive Training Intervention

Sham tDCS and Cognitive Training Intervention

Study Details

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

Study ID

NCT06413173

Start date

Jul 25, 2024

Status verified date

Nov, 2025

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Active-Duty Service Members.
2. Ages 18 to 60.
3. All genders.
4. All racial and ethnic groups.
5. 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.
6. Self-reported attention and/or concentration difficulties.
7. At least one cognitive symptom reported on the Neurobehavioral Symptom Inventory (NSI) cognitive subscale.

Exclusion Criteria:

1. 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.
2. History of prior treatment with ECT or neuromodulation in the last 12 months.
3. Current, diagnosed substance dependence.
4. Newly prescribed medication within the previous 3 weeks.
5. Diagnosis of intellectual disability or pervasive developmental disorder (i.e., premorbid IQ less than or equal to 70).
6. 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.
7. 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
8. Contraindications for tDCS (e.g., metallic cranial plates/screws or implanted device, eczema or skin lesions on scalp)
9. A positive pregnancy report.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active tDCS

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.

sham comparator: Sham tDCS

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

Interventions

Active tDCS and Cognitive Training Intervention

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.

Sham tDCS and Cognitive Training Intervention

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.

Primary outcome measure

  • Symbol Digit Modalities Test (SDMT) [ Time Frame: Baseline, 1-week post, & 6-weeks post intervention ]
  • Neuropsychological Assessment Battery (NAB) Attention Module [ Time Frame: Baseline, 1-week post, & 6-weeks post intervention ]
  • Neurobehavioral Symptom Inventory (NSI) [ Time Frame: Baseline, 1-week post, & 6-weeks post intervention ]
  • Electroencephalogram (EEG) - Resting State Functional Connectivity [ Time Frame: Baseline, 1-week post, & 6-weeks post intervention ]
  • Electroencephalogram (EEG) - Resting State Spectral Power [ Time Frame: Baseline, 1-week post, & 6-weeks post intervention ]
  • Magnetic Resonance Imaging (MRI) - T1 (optional) [ Time Frame: Baseline & 1-week post intervention ]
  • Magnetic Resonance Imaging (MRI) - T2 (optional) [ Time Frame: Baseline & 1-week post intervention ]
  • Magnetic Resonance Imaging (MRI) - T2* (optional) [ Time Frame: Baseline & 1-week post intervention ]
  • Magnetic Resonance Imaging (MRI) - DWI (optional) [ Time Frame: Baseline & 1-week post intervention ]
  • Magnetic Resonance Imaging (MRI) - ASL (optional) [ Time Frame: Baseline & 1-week post intervention ]
  • Magnetic Resonance Imaging (MRI) - ROI Analysis (optional) [ Time Frame: Baseline & 1-week post intervention ]
  • NIH Toolbox Quality of Life Assessment (NeuroQoL) [ Time Frame: Baseline, 1-week post, & 6-weeks post intervention ]
  • Insomnia Severity Index (ISI) [ Time Frame: Baseline, 1-week post, & 6-weeks post intervention ]
  • Patient Health Questionnaire (PHQ-8) [ Time Frame: Baseline, 1-week post, & 6-weeks post intervention ]
  • PTSD Checklist- Civilian Version (PCL-C) [ Time Frame: Baseline, 1-week post, & 6-weeks post intervention ]
  • Patient Global Impression of Change (PGIC) [ Time Frame: 1-week post & 6-weeks post intervention ]
  • Information Sampling Task (IST) [ Time Frame: Baseline, 1-week post, & 6-weeks post intervention ]
  • Groton Maze Learning Task (GMLT) [ Time Frame: Baseline, 1-week post, & 6-weeks post intervention ]
  • Fusion Task: BEAM [ Time Frame: Baseline, 1-week post, & 6-weeks post intervention ]
  • Fusion Task: N-Back [ Time Frame: Baseline, 1-week post, & 6-weeks post intervention ]
  • tDCS Symptom Rating Questionnaire (SRQ) [ Time Frame: Assessment collected daily during the intervention block (b/t baseline & 1-week post) ]
  • Ecological Momentary Assessment (EMA) [ Time Frame: Assessment collected daily during the intervention block (b/t baseline & 1-week post) ]

Central Contacts and Locations

Central contacts

Lars D Hungerford, PhD

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

Sean M Molnar, M.A.

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

Locations

Naval Medical Center San Diego

Recruiting

San Diego, California, United States, 92134

Contacts

Lars D Hungerford, Ph.D

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

Sean M Molnar, M.A.

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

Principal Investigator:

Lars D Hungerford, Ph.D

Minneapolis VA Health Case System

Recruiting

Minneapolis, Minnesota, United States, 55417

Contacts

Casey Gilmore, Ph.D

612.629.7466casey.gilmore2@va.gov

Florence Larkin, B.S.

612.685.7269larki124@umn.edu

Principal Investigator:

Casey Gilmore, Ph.D

More Information

Sponsor

United States Naval Medical Center, San Diego

Last update posted

Nov 12, 2025

Last verified

Nov, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by United States Naval Medical Center, San Diego on 2025-11-12.