NCT06217575 Brain Research Assessing Impacts of Neurophysiological Processing Speed Training in Veterans
| NCT ID | NCT06217575 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alabama at Birmingham |
| Condition | Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2028-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2025-07-01 with a primary completion date of 2028-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Older veterans with a history of mild brain trauma exhibit early cognitive challenges, especially in driving-related tasks. This is attributed to alterations in the brain's excitatory/inhibitory (E/I) balance. This pilot project investigates this phenomenon by leveraging electroencephalography (EEG) to measure parietal lobe alpha rhythms during visual attention tasks. The hypothesis is that targeted visual attention training can modulate these alpha rhythms, improving instrumental activities in daily life. However, outcomes from such training vary, possibly due to individual differences in cortical inhibitory functions. This study will assess the relationship between EEG measures of E/I balance pre- and post-visual attention training and its effects on processing speeds in aging veterans. Our findings aim to provide a foundation for customized therapies and interventions for veterans with and without a history of brain trauma.
Eligibility Criteria
Inclusion Criteria: Ages: 18-35 (Younger Group); Ages 50-80 (Healthy Older Group); Ages 50-85 (persons with a history of mild traumatic brain injury) * English speaking * Veterans with mild traumatic brain injury (mTBI): * A history of mTBI confirmed by the Ohio State University TBI Identification Method-Short Form (including a requirement that the mTBI caused a loss of consciousness lasting less than 30 min). * An additional note will be made for Veterans with mTBI with a report of objective or subjective cognitive decline not meeting the criteria (i.e.- Montreal Cognitive Assessment (MoCA) \>23) for impairment Exclusion Criteria: Failure to provide informed consent * Metal of foreign objects in the body that would interfere with an magnetic resonance imaging (MRI) or transcranial magnetic stimulations (TMS) * History of penetrating head wounds or a diagnosis of moderate/severe TBI * Participants with significant visual field deficits were excluded, as were those with active suicidal ideation * Suicidal ideation will be assessed with the Columbia suicidality scale (C-SSRS) * Participants with active ideation will be referred to the Veteran Crisis Line (988) (or walked) to the Front Door program at the Birmingham East clinic * Participation in a concurrent clinical trial that could affect study outcome (however, participation in standard treatments e.g. occupational therapy or use of prescribed medications such as antidepressants is acceptable) * Smoker \> 1 pack per day * Significant cognitive impairment defined as \<23 on Montreal Cognitive Assessment (MoCA) or diagnosis of mild cognitive impairment or dementia * Visual (corrected acuity \<20/80) and motor capacity (completion of 9-hole pegboard) to use a computerized intervention * In-patient status * Severe visual impairment, which would preclude completion of the assessments * Progressive, degenerative neurologic disease, e.g., Parkinsons Disease, multiple sclerosis * Severe rheumatologic or orthopedic diseases, e.g., awaiting joint replacement Actively taking GABAergic agonist/antagonist medication (benzodiazepines, gabapentin, etc.) * Terminal illness with a life expectancy of less than 12 months, as determined by a physician * Other significant co-morbid diseases that would impair the ability to participate, e.g. renal failure on hemodialysis, severe psychiatric disorder (e.g. bipolar disorder, schizophrenia), heavy alcohol use (\>15 drinks per week); persons with depression will not be excluded * Unable to communicate because of severe hearing loss, speech disorder or language barrier
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06217575 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 85 Years, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06217575 currently recruiting?
Yes, NCT06217575 is actively recruiting participants. Contact the research team at kmmcgreg@uab.edu for enrollment information.
Where is the NCT06217575 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT06217575 clinical trial?
NCT06217575 is sponsored by University of Alabama at Birmingham. The trial plans to enroll 36 participants.