Balance Study for Veterans with Traumatic Brain Injury
Balance After Traumatic Brain Injury
Recruiting
N/AInterventional Study
Traumatic Brain Injury
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
50 – 75
Sex
Any
Study type
Interventional
Purpose
Other
Participants needed
70 (estimated)
Sponsor
VA Office of Research and Development · Federal
Who this trial is looking for
This trial is looking for Veterans aged 50 to 75 who have experienced a moderate traumatic brain injury at least 10 years ago. Participants will undergo tests for balance and thinking skills to improve understanding of how a TBI affects aging.
Are You a Good Fit for This Trial?
You may be able to join if
I am aged 50 to 75.
I have had a moderate closed-head traumatic brain injury at least 10 years ago.
I consider myself fully recovered from the TBI.
I score 90 or higher on the Activities Specific Balance Confidence Scale.
I score 19 or higher on the Montreal Cognitive Assessment.
I live in the community and can travel to the research site.
You may not be able to join if
I have a neurological injury or disease other than prior TBI.
I currently have significant post-traumatic stress disorder.
I have severe arthritis that interferes with balance tasks.
I have current substance abuse issues.
I have a major depressive episode or a history of severe psychiatric illness.
I have severe obesity.
I have unstable cardiovascular disease.
I have any serious uncontrolled diabetes.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
A moderate traumatic brain injury (TBI) occurring in early or middle adulthood might have long-lasting effects on the brain that can accelerate the decline of physical and cognitive function in older age. The proposed study seeks to better understand the implications of aging with a TBI, in order to help Veterans maintain their health and independence. The overarching hypothesis of this new line o…
A moderate traumatic brain injury (TBI) occurring in early or middle adulthood might have long-lasting effects on the brain that can accelerate the decline of physical and cognitive function in older age. The proposed study seeks to better understand the implications of aging with a TBI, in order to help Veterans maintain their health and independence. The overarching hypothesis of this new line of research is that participants who experienced a moderate TBI in early or middle adulthood (at least 15 years prior to study enrollment) will have poorer performance on balance and cognitive tests, despite self-reporting no persistent motor or cognitive impairment from the TBI. The investigators also seek to evaluate the potential for practice-based learning and improvement of complex balance tasks in this population, to gain experience for conducting future rehabilitation studies. The long term goal of this line of research is to design rehabilitative and lifestyle interventions to preserve brain health and function in Veterans who have previously experienced a TBI.
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Eligibility 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 effec…
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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