Balance After Traumatic Brain Injury

NCT05714150 | Recruiting

• 2 other identifiers: E4641-PI21RX004641
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injury; aging; balance; cognition

Outcome Measures

Primary Outcomes (1)

• Center of Pressure (COP) control

  Participants will receive real-time feedback of their center of pressure location, by observing a tracing on a television screen. They will shift their body weight in order to move the center of pressure, and will attempt to follow a pre-defined trajectory that is shown on the screen.

  Change from baseline COP control, measured immediately following a single intervention session (the session will include 30 minutes)

Study Arms (1)

Balance Intervention

EXPERIMENTAL

Participants with TBI history and without TBI history will both complete the same intervention.

Behavioral: Complex Balance Tasks

Interventions

Complex Balance Tasks BEHAVIORAL

The intervention will consist of a single session of practicing complex (cognitively engaging) balance tasks using an exergaming balance platform.

Balance Intervention

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

Gainesville, Florida, 32608-1135, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• David J. Clark, DSc

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David J Clark, DSc

CONTACT

(352) 376-1611; David.Clark1@va.gov

Brigette Cox, BS

CONTACT

(352) 376-1611; brigette.cox@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The intervention will consist of a single session of practicing complex (cognitively engaging) balance tasks using an exergaming balance platform. The session will include 30 minutes of practice. Participants with TBI history and without TBI history will both complete the same intervention.

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: February 6, 2023
• Study Start: March 21, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available after the study is closed to enrollment. Data will remain available for at least 6 years in accordance with VA records management policy.
• Access Criteria: Data can be accessed by contacting the Principal Investigator directly.

Locations

US (1)