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

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

Interventions

COMBINATION_PRODUCT

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.

COMBINATION_PRODUCT

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.

Sponsors & Collaborators

• Minneapolis Veterans Affairs Medical Center

  collaborator FED

• University of Minnesota

  collaborator OTHER

• United States Department of Defense

  collaborator FED

• Center for Veterans Research and Education

  collaborator OTHER

• The Defense and Veterans Brain Injury Center

  collaborator FED

• General Dynamics Information Technology

  collaborator UNKNOWN

• United States Naval Medical Center, San Diego

  lead FED

Principal Investigators

• Lars D Hungerford, PhD · United States Naval Medical Center, San Diego

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-25

Primary Completion

2028-09-30

Completion

2028-09-30

Countries

• United States

Study Locations