Recruiting

Neuro-Cognitive Skills

Sponsor:

VA Office of Research and Development

Code:

NCT04109027

Conditions

TBI

Cognitive Dysfunction

Eligibility Criteria

Sex: All

Age: 21 - 60

Healthy Volunteers: Not accepted

Interventions

BrainStrong-BSR

BrainStrong-OPT

Study Details

Brief summary:

For many Veterans, success in achieving goals at work, school and in other aspects of life are top priorities. The abilities to regulate attention, remember key information, and stay calm and on track are fundamental to this success. Unfortunately, Veterans who have experienced a traumatic brain injury (TBI) often struggle with these very abilities, and a number of barriers can make it difficult for them to access the help Veterans need. Tele-rehabilitation has the potential to overcome some of these barriers and increase access to care, enabling providers to better reach Veterans 'where they are' in their communities. This project will assess two different approaches to brain injury rehabilitation that seek to help Veterans build personal strengths to better accomplish their goals. Both approaches will be delivered remotely via tele-rehabilitation and augmented by digital apps to best support Veterans' learning in community settings outside the VA.

Conditions

TBI

Cognitive Dysfunction

Study ID

NCT04109027

Start date

Jun 10, 2024

Status verified date

Oct, 2026

Completion date

Jun 5, 2028

Anticipated

Primary completion date

Mar 13, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Post 9/11 Veterans
  • history of mild-moderate traumatic brain injury (including reported mechanism of head injury and alteration of consciousness)
  • in the chronic, stable phase of recovery (>6 months from injury); with at least 1 self-reported cognitive symptom --including difficulties with working memory; and interested in goal-setting and intensive training

Exclusion Criteria:

  • Severely apathetic/abulic, aphasic, or other reasons for being unable or unwilling to participate in training
  • severe cognitive dysfunction (below 2 standard deviations on two composite cognitive domains)
  • schizophrenia
  • bipolar disorder
  • history of other neurological disorders
  • current medical illnesses that may alter mental status or disrupt participation in the study
  • active psychotropic medication changes
  • symptom magnification or malingering

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BrainStrong-BSR

Goal-integerated Brain State Regulation Training (BSR)

active comparator: BrainStrong-OPT

Education on Optimization of Brain Functioning (OPT)

Interventions

BrainStrong-BSR

Training in Goal-integrated Brain State Regulation Skills

BrainStrong-OPT

Education on Optimization of Brain Functioning (OPT)

Primary outcome measure

  • Selective Information Processing [ Time Frame: Change from baseline to 2 weeks post-intervention ]

Central Contacts and Locations

Central contacts

Jeanette M Cope

(916) 843-7512Jeanette.Cope@va.gov

Juliana V Baldo, PhD

(925) 372-4649Juliana.Baldo@va.gov

Locations

VA Northern California Health Care System, Mather, CA

Recruiting

Sacramento, California, United States, 95655-4200

Contacts

Jefferson Lee

(916) 843-2769Jefferson.Lee2@va.gov

Lucita E Echaluse, BSN

(916) 843-7195lucita.echaluse@va.gov

Principal Investigator:

Anthony J. W. Chen, MD MA

More Information

Sponsor

VA Office of Research and Development

Last update posted

Oct 21, 2026

Last verified

Oct, 2026

Keywords

  • attention
  • working memory
  • executive functioning

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-10-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.