RECRUITING

Brain Balance Study

Conditions

Traumatic Brain Injury aging balance cognition

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Aging With a Traumatic Brain Injury: Implications for Balance Deficits and Fall Risk

Quick Facts

Study Start:2024-03-21

Study Completion:2025-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05714150

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age 50-65. 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	* 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.

Inclusion Criteria

Exclusion Criteria

* Age 50-65. 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

* 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.

Contacts and Locations

Study Contact

David J Clark, DSc

CONTACT

(352) 376-1611

David.Clark1@va.gov

Brigette Cox, BS

CONTACT

(352) 376-1611

brigette.cox@va.gov

Principal Investigator

David J. Clark, DSc

PRINCIPAL_INVESTIGATOR

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

Study Locations (Sites)

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

Gainesville, Florida, 32608-1135

United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

David J. Clark, DSc, PRINCIPAL_INVESTIGATOR, North Florida/South Georgia Veterans Health System, Gainesville, FL

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-21

Study Completion Date2025-06-30

Study Record Updates

Study Start Date2024-03-21

Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

traumatic brain injury
aging
balance
cognition

Additional Relevant MeSH Terms

Traumatic Brain Injury