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Veterans with old brain injuries may face hidden balance risks

NCT ID NCT05714150

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 30, 2026 · Updated 3 times

Summary

This study looks at how a moderate traumatic brain injury (TBI) from early or middle adulthood might speed up physical and mental decline in older age. Researchers will test balance and thinking in 70 Veterans aged 50-75 who had a TBI at least 15 years ago, even if they feel fine now. The goal is to understand these hidden effects and pave the way for future rehab programs to help Veterans stay healthy and independent.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

21 people

The number who actually took part.

Started

Mar 2024

Finished

Jun 2026

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • North Florida/South Georgia Veterans Health System, Gainesville, FL

    Gainesville, Florida, 32608-1135, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.