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

Key facts

Who runs it
United States Naval Medical Center, San Diego
Where
Minneapolis and San Diego, United StatesSee the 2 sites
Trial code
Status
Recruiting
People taking part
160 people, planned
Started
25 Jul 2024
Expected to end
30 Sept 2028
Type of study
Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
Treatments tested
  • Active tDCS and Cognitive Training Intervention
  • Sham tDCS and Cognitive Training Intervention
Record updated
13 November 2026

Who can take part

Age
18 years to 60 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • History of prior treatment with ECT or neuromodulation in the last 12 months
  • Newly prescribed medication within the previous 3 weeks
  • 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
  • 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
  • Current, diagnosed substance dependence
  • Contraindications for tDCS (e.g., metallic cranial plates/screws or implanted device, eczema or skin lesions on scalp)
  • A positive pregnancy report

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 60 years old?

Where in United States

  • Minneapolis VA Health Case SystemMinneapolis, United StatesContact: Casey Gilmore, Ph.DTaking people
  • Naval Medical Center -San DiegoSan Diego, United StatesContact: Lars D Hungerford, Ph.DTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Active tDCSTreatment being tested

    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.

    Treatment: Active tDCS and Cognitive Training Intervention

  • Sham tDCSSham treatment, for comparison

    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

    Treatment: Sham tDCS and Cognitive Training Intervention

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Remotely Supervised tDCS Combined With Cognitive Training to Improve Complex Attention in Active Duty Service Members and Veterans With Mild TBI (Cognetric)
Fit questions
Built from NCT06413173, who can take part
Record updated
13 November 2026