Understanding balance and cognition in veterans with past brain injuries
Aging With a Traumatic Brain Injury: Implications for Balance Deficits and Fall Risk
This study is trying to see if veterans aged 50-65 who had a brain injury many years ago still have balance and thinking problems compared to their peers without a brain injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 50 Years to 75 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Drugs / interventions | prednisone |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT05714150 on ClinicalTrials.gov |
What this trial studies
This study investigates the long-term effects of moderate traumatic brain injury (TBI) on balance and cognitive function in veterans aged 50-65 who experienced a TBI at least 15 years prior. It aims to determine whether these individuals, despite feeling fully recovered, show poorer performance on balance and cognitive tests compared to their peers without a TBI. The research will involve complex balance tasks to assess performance and gather insights for future rehabilitation interventions. The ultimate goal is to develop strategies that help veterans maintain their health and independence as they age.
Who should consider this trial
Good fit: Ideal candidates are veterans aged 50-65 with a history of moderate closed-head TBI occurring at least 10 years prior.
Not a fit: Patients who have not experienced a moderate TBI or are outside the age range of 50-65 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to targeted interventions that help veterans preserve their physical and cognitive functions as they age.
How similar studies have performed: While there is accumulating evidence regarding the effects of TBI on aging, this specific approach to understanding balance and cognition in veterans is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Enrollment Criteria for Participant with TBI (TBI+ group) Inclusion criteria * Age 50-75. People of this age normally do not exhibit substantial balance or cognitive impairments, so observing a clear deficit between groups will provide compelling evidence of a TBI-related effect. This "younger old" age group will also help to avoid other comorbid health conditions of older age that would increase variability (uncertainty) in the data set. * Prior history of moderate closed-head TBI at least 10 years prior to study enrollment. Single or multiple TBIs are acceptable. All participants who self-report a prior TBI will complete a standardized interview called the Ohio State University TBI Identification Method (OSU TBI-ID) to characterize and confirm the occurrence of a prior moderate TBI. Moderate TBI will be defined as any of the following: * loss of consciousness from 30 minutes to 24 hours * and/or alteration of consciousness/mental state for greater than 24 hours * and/or post-traumatic amnesia for \>1 to \<7 days * and/or abnormal structural imaging confirmed by medical records * Affirmative response to the question: "At the present time, do you consider yourself to be fully recovered from the TBI?" * Score on the Activities Specific Balance Confidence Scale of 90 or higher (out of 100 possible points), which indicates absence of self-reported balance/mobility deficits. * Score of 19 or higher on the telephone version of the Montreal Cognitive Assessment, which indicates absence of major cognitive impairment. * living in the community and able to travel to the research site Exclusion Criteria: Enrollment Criteria for Participant with TBI (TBI+ group) Exclusion criteria * Neurological injury or disease other than prior history of moderate TBI * Current clinically significant post-traumatic stress disorder (PCL score \>30) * severe arthritis, such as awaiting joint replacement, that would interfere with participation balance/mobility tasks * Current substance abuse * Current uncontrolled major depressive episode, history of severe psychiatric illness unrelated to TBI (e.g., bipolar 1 or schizophrenia). * severe obesity (body mass index \> 35) * unstable cardiovascular disease (for example, recent angina or uncontrolled high blood pressure) * lung disease requiring use of supplemental oxygen * renal disease requiring dialysis * serious uncontrolled diabetes * terminal illness * myocardial infarction or major heart surgery in the previous year * cancer treatment in the past year, except for nonmelanoma skin cancers and cancers having an excellent prognosis (e.g., early stage breast or prostate cancer) * uncontrolled hypertension at rest (systolic \> 180 mmHg and/or diastolic \> 100 mmHg) * bone fracture in the previous year * hip joint replacement or metal implants that would preclude accurate assessment of lean mass or hip bone mineral density * Use of any pharmacologic agents (within past 180-days) that are known to influence BMD, including anti-resorptive or bone anabolic therapies, any compounded or over-the-counter androgenic hormone or androgen precursor, clomiphene, aromatase inhibitors, anti-estrogen or estrogen treatment, or growth hormone? * Chronic use of systemic glucocorticoids \>7.5 mg/d prednisone equivalent (e.g., hydrocortisone 30 mg, methylprednisolone 6 mg, or dexamethasone 1.2 mg) * current participation in physical therapy for lower extremity function * current enrollment in a clinical trial that might jeopardize safety or scientific integrity of either trial * unable to communicate sufficiently with study personnel, and/or non-English speaking * other medical conditions other that would adversely affect balance, cognition, or oculomotor function. * clinical judgment of investigative team regarding safety or non-compliance.
Where this trial is running
Gainesville, Florida
- North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: David J. Clark, DSc — North Florida/South Georgia Veterans Health System, Gainesville, FL
- Study coordinator: David J Clark, DSc
- Email: David.Clark1@va.gov
- Phone: (352) 376-1611
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.