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Brain Balance Study

Primary Purpose

Traumatic Brain Injury

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Complex Balance Tasks
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Traumatic Brain Injury focused on measuring traumatic brain injury, aging, balance, cognition

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Enrollment Criteria for Participant with TBI (TBI+ group) Inclusion 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 15 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.

Sites / Locations

  • North Florida/South Georgia Veterans Health System, Gainesville, FLRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Balance Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 17, 2023
Last Updated
July 31, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05714150
Brief Title
Brain Balance Study
Official Title
Aging With a Traumatic Brain Injury: Implications for Balance Deficits and Fall Risk
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2023 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Accumulating research indicates that a TBI sustained in early or middle adulthood has the potential to influence the trajectory of the aging process, both in the context of brain function and whole-body health. People who consider themselves to be fully recovered and asymptomatic many years following a brain injury might actually exhibit poorer function than peers who did not experience a head injury. The TBI literature reveals compelling evidence that TBI can elicit long-term abnormal cascades of neuroendocrine and neuroinflammatory processes that alter the structural and functional integrity of brain networks. However, there is little direct evidence to establish whether "normal" age-related neurodegeneration and decline of physical and cognitive function are made worse by a TBI that occurred many years earlier. By understanding the chronic effects of "aging with a TBI" the investigators can better identify potential interventions to reduce negative repercussions across the lifespan. This is an important area of investigation, considering there is a substantial window of opportunity for Veterans who have experienced a TBI to engage in rehabilitative interventions and lifestyle modifications that may preserve function as they transition to older age. 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, in order to gain experience for conducting future rehabilitation studies. Veterans with prior TBI (TBI+ group) will be compared to a control group who report no history of TBI (TBI- group). The investigators propose to enroll Veterans who are transitioning into older age (i.e., age between 50-65 years). This study will focus on balance function because of its close association with fall risk. Falls and resultant injuries are a major cause of disability in older Veterans and civilians, which poses a substantial rehabilitation demand and cost to individuals and society. The significance of balance deficits and falls will only grow in the coming years, as more than 50% of all Veterans will be 65 years or older by 2050. Further, loss of balance is very common in the acute stage of recovery from TBI, suggesting damage to neural control pathways/networks that might be susceptible to chronic effects. As secondary outcomes, the investigators will conduct assessments that are related to balance function (including cognitive and oculomotor function) and that increase the risk of injuries due to a fall (bone mineral density). The TBI literature suggests that these secondary outcomes are also susceptible to the chronic effects of a TBI. The first aim of the study is to determine if TBI+ participants have impaired balance, cognition, and oculomotor performance compared to TBI- participants. The second aim of the study is to evaluate the potential for practice-based learning of balance tasks requiring visuospatial cognitive engagement. In addition to the proposed group analyses, the investigators will also conduct exploratory regression analysis within the TBI+ participants to examine potential relationships between the severity of injury and continuous measures of motor and cognitive performance. The knowledge and experience gained from this study will prepare to conduct larger studies to better understand the chronic effects of aging with a TBI, as well as prepare to test rehabilitation interventions to promote healthy aging in this population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
traumatic brain injury, aging, balance, cognition

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Balance Intervention
Arm Type
Experimental
Arm Description
Participants with TBI history and without TBI history will both complete the same intervention.
Intervention Type
Behavioral
Intervention Name(s)
Complex Balance Tasks
Intervention Description
The intervention will consist of a single session of practicing complex (cognitively engaging) balance tasks using an exergaming balance platform.
Primary Outcome Measure Information:
Title
Center of Pressure (COP) control
Description
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.
Time Frame
Change from baseline COP control, measured immediately following a single intervention session (the session will include 30 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Enrollment Criteria for Participant with TBI (TBI+ group) Inclusion 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 15 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David J Clark, DSc
Phone
(352) 376-1611
Ext
5244
Email
David.Clark1@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Brigette Cox, BS
Phone
(352) 376-1611
Ext
107735
Email
brigette.cox@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J. Clark, DSc
Organizational Affiliation
North Florida/South Georgia Veterans Health System, Gainesville, FL
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Florida/South Georgia Veterans Health System, Gainesville, FL
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608-1135
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Merritt
Phone
352-548-6000
Ext
6476
Email
michael.merritt@va.gov
First Name & Middle Initial & Last Name & Degree
Margaret H McCallum
Phone
(352) 376-1611
Ext
5223
Email
Margaret.McCallum@va.gov
First Name & Middle Initial & Last Name & Degree
David J. Clark, DSc

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
A de-identified, anonymized dataset will be created and shared pursuant to a Data Use Agreement appropriately describing use of the dataset and prohibiting the recipient from identifying or re-identifying any individual whose data are included in the dataset. All individually identifiable information for the study will be handled in full compliance with policies outlined by the University of Florida Institutional Review Board and by the NF/SG VHA Human Research Protections Program.
IPD Sharing 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.
IPD Sharing Access Criteria
Data can be accessed by contacting the Principal Investigator directly.

Learn more about this trial

Brain Balance Study

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