Brain Balance Study
- Conditions
- Traumatic Brain Injury
- Registration Number
- NCT05714150
- Lead Sponsor
- VA Office of Research and Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br>Enrollment Criteria for Participant with TBI (TBI+ group) Inclusion criteria<br><br> - Age 50-65. People of this age normally do not exhibit substantial balance or<br> cognitive impairments, so observing a clear deficit between groups will provide<br> compelling evidence of a TBI-related effect. This younger old age group will also<br> help to avoid other comorbid health conditions of older age that would increase<br> variability (uncertainty) in the data set.<br><br> - Prior history of moderate closed-head TBI at least 10 years prior to study<br> enrollment. Single or multiple TBIs are acceptable. All participants who self-report<br> a prior TBI will complete a standardized interview called the Ohio State University<br> TBI Identification Method (OSU TBI-ID) to characterize and confirm the occurrence of<br> a prior moderate TBI. Moderate TBI will be defined as any of the following:<br><br> - loss of consciousness from 30 minutes to 24 hours<br><br> - and/or alteration of consciousness/mental state for greater than 24 hours<br><br> - and/or post-traumatic amnesia for >1 to <7 days<br><br> - and/or abnormal structural imaging confirmed by medical records<br><br> - Affirmative response to the question: At the present time, do you consider yourself<br> to be fully recovered from the TBI?<br><br> - Score on the Activities Specific Balance Confidence Scale of 90 or higher (out of<br> 100 possible points), which indicates absence of self-reported balance/mobility<br> deficits.<br><br> - Score of 19 or higher on the telephone version of the Montreal Cognitive Assessment,<br> which indicates absence of major cognitive impairment.<br><br> - living in the community and able to travel to the research site<br><br>Exclusion Criteria:<br><br>Enrollment Criteria for Participant with TBI (TBI+ group) Exclusion criteria<br><br> - Neurological injury or disease other than prior history of moderate TBI<br><br> - Current clinically significant post-traumatic stress disorder (PCL score >30)<br><br> - severe arthritis, such as awaiting joint replacement, that would interfere with<br> participation balance/mobility tasks<br><br> - Current substance abuse<br><br> - Current uncontrolled major depressive episode, history of severe psychiatric illness<br> unrelated to TBI (e.g., bipolar 1 or schizophrenia).<br><br> - severe obesity (body mass index > 35)<br><br> - unstable cardiovascular disease (for example, recent angina or uncontrolled high<br> blood pressure)<br><br> - lung disease requiring use of supplemental oxygen<br><br> - renal disease requiring dialysis<br><br> - serious uncontrolled diabetes<br><br> - terminal illness<br><br> - myocardial infarction or major heart surgery in the previous year<br><br> - cancer treatment in the past year, except for nonmelanoma skin cancers and cancers<br> having an excellent prognosis (e.g., early stage breast or prostate cancer)<br><br> - uncontrolled hypertension at rest (systolic > 180 mmHg and/or diastolic > 100 mmHg)<br><br> - bone fracture in the previous year<br><br> - hip joint replacement or metal implants that would preclude accurate assessment of<br> lean mass or hip bone mineral density<br><br> - Use of any pharmacologic agents (within past 180-days) that are known to influence<br> BMD, including anti-resorptive or bone anabolic therapies, any compounded or<br> over-the-counter androgenic hormone or androgen precursor, clomiphene, aromatase<br> inhibitors, anti-estrogen or estrogen treatment, or growth hormone?<br><br> - Chronic use of systemic glucocorticoids >7.5 mg/d prednisone equivalent (e.g.,<br> hydrocortisone 30 mg, methylprednisolone 6 mg, or dexamethasone 1.2 mg)<br><br> - current participation in physical therapy for lower extremity function<br><br> - current enrollment in a clinical trial that might jeopardize safety or scientific<br> integrity of either trial<br><br> - unable to communicate sufficiently with study personnel, and/or non-English speaking<br><br> - other medical conditions other that would adversely affect balance, cognition, or<br> oculomotor function.<br><br> - clinical judgment of investigative team regarding safety or non-compliance.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Center of Pressure (COP) control
- Secondary Outcome Measures
Name Time Method