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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 60 Years

Healthy Volunteers

Not accepted

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.
• 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.

Study Details

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.

Key Dates

Start date

Jul 25, 2024

Status verified

Nov 2025

Primary completion

Sep 30, 2028

Completion

Sep 30, 2028

Study Design

Enrollment

160 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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

Primary Outcome Measure

Symbol Digit Modalities Test (SDMT) [ Time Frame: Baseline, 1-week post, & 6-weeks post intervention ]

Central Contacts

• Lars D Hungerford, PhD
  619.532.5715
  [email protected]
• Sean M Molnar, M.A.
  424.341.8860
  [email protected]

Locations (2)

Find similar trials in San Diego, CA

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