Status:
RECRUITING
Brain Research Assessing Impacts of Neurophysiological Processing Speed Training in Veterans
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
Birmingham VA Health Care System
Conditions:
Traumatic Brain Injury
Mild Traumatic Brain Injury
Eligibility:
All Genders
50-85 years
Phase:
NA
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)...
Detailed Description
Veterans aged 50 and above who have suffered mild traumatic brain injury (mTBI) are twice as prone to develop dementia. From 2001, during the Operation Enduring Freedom (OEF) and Operation Iraqi Freed...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06217575
Start Date
July 1 2025
End Date
April 1 2028
Last Update
August 29 2025
Active Locations (1)
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1
CH19 933 19th St S
Birmingham, Alabama, United States, 35223