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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 75
Healthy Volunteers: t
View:

∙ 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

Locations
United States
Florida
North Florida/South Georgia Veterans Health System, Gainesville, FL
RECRUITING
Gainesville
Contact Information
Primary
David J Clark, DSc
David.Clark1@va.gov
(352) 376-1611
Backup
Brigette Cox, BS
brigette.cox@va.gov
(352) 376-1611
Time Frame
Start Date: 2024-03-21
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 70
Treatments
Experimental: Balance Intervention
Participants with TBI history and without TBI history will both complete the same intervention.
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov