Enhancing cognitive training for veterans with traumatic brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The CONNECT-TBI Trial aims to develop effective treatments for complex mild traumatic brain injury (mTBI) that improve cognitive functioning in veterans. This randomized, double-blinded, sham-controlled clinical trial will assess the effects of Attention Process Training (APT-3) combined with either repetitive Transcranial Magnetic Stimulation (rTMS), High-Definition Transcranial Direct Current Stimulation (HD-tDCS), or sham stimulation. Participants will undergo comprehensive assessments including neuropsychological testing, MRI scans, and cognitive evaluations to identify cognitive control deficits. The study seeks to address the debilitating cognitive symptoms associated with mTBI and prolonged post-concussive symptoms (PPCS).

Why it matters

Who can join: the full rules

Inclusion Criteria:

There will be no gender restrictions with regard to sample inclusion. Veterans and Warfighters will be enrolled in this study if they 1) are aged 18-59; 2) have suffered a mild TBI with documented evidence of alteration in neurological functioning or loss of consciousness (LOC) which was less than 30 minutes; 3) were injured between 3 months and 5 years ago; 4) experienced less than 24 hours of post-traumatic amnesia (PTA); 5) have subjective post-TBI cognitive deficits as assessed by the NSI, with at least 1 of 4 cognitive symptoms at a score of 3 or higher (severe disturbance) or at least 2 of 4 cognitive symptoms at a score of 2 or higher (moderate disturbance). This is the target population as identified by the grant mechanism, with chronic cognitive impairments from mild traumatic brain injury. The age range of 18-59 years was selected because the investigators did not want to include developmental processes in analyses and by 18 years old, many major neurodevelopmental changes in the brain will have taken place. Using similar rationale, the investigators chose to include participants up to the age of 59 because they do not want to include advancing age-related brain changes in our analyses. They will also be 6) fluent in English, as the testing and intervention are all conducted in English; and 7) will have been on stable doses of any psychotropic medications for the past 2 months, so as to avoid confounding of results by medication effects. It is expected that the sample included in this study will reflect the demographics of the greater Albuquerque and Twin Cities metropolitan communities.

Exclusion Criteria:

Veterans will be excluded from participation in this study if there is 1) a prior history of other neurological disease or any history of seizures beyond immediate post-traumatic seizure, so as to reduce risk of exacerbation of epilepsy or other neurological symptoms; 2) history of psychosis, so as to reduce risk of psychiatric decompensation; 3) history of current or recent (within two years) substance/alcohol dependence, to reduce confounding effects on cognition; 4) any discontinuity in skull electrical conductivity (i.e., unhealed burr holes in scalp) or artificially constructed (metal or plastic) craniotomy cover, to reduce risk of unimpeded electrical current; 5) presence of any implanted metal or electrical device (e.g. pacemaker), to reduce risk of heating during MRI, or device malfunction during neuromodulation; 6) recent medical hospitalization (within three weeks), to reduce risk of medical decompensation during the study; 7) any condition that would prevent the participant from completing the protocol, such as significant agitation; 8) appointment of a legal representative, as assessed via direct inquiry of the participant or a designated trusted other, to avoid coercion of a vulnerable population; 9) any significant hardness of hearing or blindness that would make completing the cognitive training not possible; 10) any ongoing litigation related to TBI, to prevent interference with legal proceedings; 11) any other contraindication to exposure to strong magnetic fields or MRI, such as severe claustrophobia; 12) pregnant women will be excluded as the effects of MRI and brain stimulation on developing fetuses are unknown; 13) membership in an identified vulnerable population, including minors, and prisoners, and adults unable to consent due to cognitive impairment will be excluded, as they will be unlikely to be able to complete study procedures. Prisoners will be excluded from the study to avoid coercion; 14)received a Glasgow coma scale (GCS) less than 13 or greater than 15 upon ED admission, if available in patient's records.

The investigators do not intend to include adults who are unable to consent in this study.

The investigators do not intend to include individuals who are not yet adults (infants, children, teenagers) in this study.

The investigators do not intend to include pregnant women in this study.

The investigators do not intend to include prisoners in this study.

Where it's running

• Minneapolis Veterans Affairs Medical Center
  Minneapolis, Minnesota, United States Recruiting
• New Mexico Veterans Affairs Health Care System
  Albuquerque, New Mexico, United States Recruiting
• The University of Minnesota
  Minneapolis, Minnesota, United States Active not recruiting
• The Mind Research Network
  Albuquerque, New Mexico, United States Active not recruiting
• The University of New Mexico
  Albuquerque, New Mexico, United States Active not recruiting

Study contacts

• Principal investigator: Davin k Quinn, MD, FACLP — University of New Mexico
• Study coordinator: Cesar J Ojeda, MBA
• Email: cojeda1@salud.unm.edu
• Phone: (505)272-6972

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• PIONEER-Prognosis: Using biomarkers and wearables to forecast recovery after mild traumatic brain injury

  This study tests whether blood biomarkers, health data from records, and wearables can help predict how people recover after a mild traumatic brain injury treated in the emergency department.

  Recruiting at 3 sites University of Michigan · Torrance, California and 4 other locations · NCT07858266

• HBOT to see if it helps cognition and well‑being in first responders with prior brain injury

  This study tests whether 40 hyperbaric oxygen therapy sessions can improve thinking skills and post-concussion symptoms in current or former first responders with a history of brain injury.

  Recruiting Phase 2 Summit Hyperbarics and Wellness · Boise, Idaho · NCT07852728

• Depth Electrode Monitoring after Traumatic Brain Injury

  This study tests adding a depth electrode with continuous brain monitoring during external ventricular drain placement in adults with traumatic brain injury to see if cortical reverberation signals can be tracked safely.

  Recruiting Hennepin Healthcare Research Institute · Minneapolis, Minnesota · NCT07842458

• Understanding growth hormone deficiency after a brain injury in adults

  This observational study tests whether growth hormone deficiency affects quality of life and symptoms in adults with traumatic brain injury and whether GH replacement helps after 12 weeks.

  Recruiting University of Calgary · Calgary, Alberta and 1 other locations · NCT07795736

• Electrical stimulation-assisted exercise for people with lower limb paralysis

  This study tests whether adding electrical stimulation during exercise can improve leg muscle strength and endurance for people with paralysis.

  Recruiting Louis Stokes VA Medical Center · Cleveland, Ohio · NCT07768761

• ZEPU-2000 robotic rehab for arm and leg weakness

  This trial tests whether adding ZEPU-2000A, ZEPU-2000D, and ZEPU-2000E robotic rehabilitation to usual therapy helps adults with arm/leg movement problems from stroke, incomplete SCI, TBI, or related conditions.

  Recruiting Bangladesh Medical University · Dhaka · NCT07749612

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.