Traumatic Brain InjuryNCT05714150
Balance After Traumatic Brain Injury
A study testing Complex Balance Tasks in people with Traumatic Brain Injury, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Complex Balance Tasks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608-1135
About this study
Official title: Aging With a Traumatic Brain Injury: Implications for Balance Deficits and Fall Risk
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.
Read the 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Complex Balance Tasks
- Keywords
- traumatic brain injury, aging, balance, cognition
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex Balance TasksBehavioural
The intervention will consist of a single session of practicing complex (cognitively engaging) balance tasks using an exergaming balance platform.
| Study group | Role | What they receive |
|---|---|---|
| Balance Intervention | Experimental | Participants with TBI history and without TBI history will both complete the same intervention. Receives: Behavioral: Complex Balance Tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline COP control, measured immediately following a single intervention session (the session will include 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start21 Mar 2024
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- David J. Clark, DSc, Principal investigator, North Florida/South Georgia Veterans Health System, Gainesville, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714150
- Sponsor's protocol ID
- E4641-P
- Other IDs
- I21RX004641
- Status last verified
- Jul 2026
- First submitted
- 17 Jan 2023
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aging With a Traumatic Brain Injury: Implications for Balance Deficits and Fall Risk
- ClinicalTrials.gov ID
- NCT05714150
- Acronym / sponsor ID
- E4641-P
- Conditions
- Traumatic Brain Injury
- Keywords
- traumatic brain injury, aging, balance, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Balance Intervention | Experimental | Behavioral: Complex Balance TasksParticipants with TBI history and without TBI history will both complete the same intervention. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- 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.
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complex Balance TasksThe intervention will consist of a single session of practicing complex (cognitively engaging) balance tasks using an exergaming balance platform. | Behavioural | Balance Intervention |
Primary outcome
Center of Pressure (COP) control
Time frame: Change from baseline COP control, measured immediately following a single intervention session (the session will include 30 minutes)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David J. Clark, DSc principal investigator
North Florida/South Georgia Veterans Health System, Gainesville, FL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complex Balance Tasks in people with Traumatic Brain Injury, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Center of Pressure (COP) control (time frame: Change from baseline COP control, measured immediately following a single intervention session (the session will include 30 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.