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Mild Traumatic Brain InjuryNCT07569354

Recovery Among Older Adults Following Mild TBI

An observational study of Mild Traumatic Brain Injury, run by University of Maryland, Baltimore at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Among fall related injuries in older adults, head injuries are the most common, yet almost nothing is known about recovery from head injury, also known as traumatic brain injury or TBI, in this population. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Mild Traumatic Brain Injury
How many people
250 participants
Where
1 siteUnited States
Study dates
11 May 2023to 31 Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: Study population consists of adults aged 65 or older who live within 55 miles of the University of Maryland Medical Center and who have been treated for a mild traumatic brain injury at a participating emergency department within 72 hours of injury.

Who may be able to join

  • Aged 65 years or older
  • Treated for mild TBI (defined below) at the R Adams Cowley Shock Trauma Center (STC) or at one of six University of Maryland Affiliated Hospitals within 72 hours of injury
  • Mild TBI was defined as:
  • Traumatically induced physiological disruption of brain function, as manifested by at least one of the following 1) loss of consciousness ≤30 minutes, post-traumatic amnesia <24 hours, observed or self-reported transient confusion, disorientation, or impaired consciousness, or neurologic deficit as defined by a Glasgow Coma Scale (GCS) score of 13-14 on admission.
  • GCS of 15 with no other evidence of mild TBI was also accepted with positive computed tomography image.

Who cannot join

  • Injury to any other body region resulting in an abbreviated injury scale (AIS) score >2
  • Anticipation that patient would not be ambulatory at 2-weeks post-injury
  • History of dementia as determined by patient/proxy report or medical history
  • Non-ambulatory pre-injury
  • No available proxy
  • Not English speaking
  • Prisoners
  • Live >55 miles from the STC.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • University of Maryland, Baltimore

    Baltimore, Maryland, 21201

    Michelle Newman, BSN, 410-706-0933 ext. 410-706-0071, mnewman@som.umaryland.edu

    Jennifer Albrecht, PhD, 410-706-0071 ext. 410-706-0071, jalbrecht@som.umaryland.edu

    Recruiting

Other trials in United States

About this study

Among fall related injuries in older adults, head injuries are the most common, yet almost nothing is known about recovery from head injury, also known as traumatic brain injury or TBI, in this population. The RETRO-TBI study is a prospective cohort study of 250 adults aged 65 and older with mild TBI to evaluate recovery in cognitive, physical and psychological function and sleep quality at four timepoints (2 weeks and 3, 6, and 12 months) over the year following injury and identify factors associated with recovery trajectories. The potential impact of this work is that it will generate new knowledge that will guide targeted treatment efforts and inform future development of strategies to optimize recovery following this common fall-related injury among older adults.

Read the detailed description

Development of Alzheimer's disease and related dementias (ADRD) is multifactorial, and some causal factors can be influenced or modified. Recently, the Lancet Commission included traumatic brain injury (TBI) in its list of 12 key potentially modifiable ADRD risk factors. TBI is a very common injury among older adults, resulting in over 123,000 hospitalizations and 485,000 emergency department visits annually. Importantly, rates of TBI are rapidly increasing in this population. TBI results in cognitive impairment and increases risk for both Alzheimer's disease and fronto-temporal dementia. Furthermore, TBI can result in worsened health outcomes (e.g., poor cognitive and physical functioning, psychological distress, worsened sleep quality), which in turn increase risk for ADRD. Yet, despite the large public health impact of TBI among older adults, little is known about changes in cognition and related domains following discharge from acute care in this population. Although such information is urgently needed to guide rehabilitation, care planning, and promotion of optimal long-term recovery in this vulnerable population, these data are severely lacking in the literature. One major reason for this lack of knowledge is that most prior research on TBI has focused on younger adults. Unfortunately, many findings from younger adults do not generalize to older adults due to their higher comorbidity burden and poorer cognitive and physical functioning at discharge from acute care. The objective of the proposed research is to gain an in-depth understanding of recovery of cognition, psychological and physical functioning, and sleep quality following TBI among older adults. To achieve this objective, the investigators propose to conduct a prospective cohort study of 250 patients aged 65 years and older treated for mild TBI at the R Adams Cowley Shock Trauma Center or at one of six University of Maryland Medical System affiliated hospitals with follow-up at 2 weeks and 3, 6, and 12 months to complete three Specific Aims: 1) Assess recovery of cognitive functioning and identify predictors of poor recovery; 2) Assess recovery of physical and psychological functioning and sleep quality and identify predictors of poor recovery; 3) Identify interactions between recovery trajectories.

The significance of this research is that it will identify unique recovery patterns across important domains of functioning (including cognitive function) and factors that impact the course of recovery following mild TBI among older adults. Identification of individuals at risk for poor cognitive recovery following TBI will highlight a population at high risk of ADRD and would permit targeting those individuals with cognitive rehabilitation interventions, potentially reducing ADRD risk. The rationale for the proposed study is that early identification of patients with poorer recovery trajectories will permit development and targeting of appropriately timed interventions to mitigate ADRD risk and other adverse outcomes. The potential impact of this work is that it will generate new knowledge that will guide targeted treatment efforts and inform development of a geriatric-TBI focused rehabilitation intervention that will be the focus of a future R01 application.

Keywords
TBI, Older adults
Medical subject headings
Brain Concussion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical function

    Short Physical Performance Battery total score. Range 0-12, Higher scores indicating better lower extremity function

    Measured: 2 weeks, 3, 6, and 12 months

  2. Cognition

    Repeatable Battery for the Assessment of Neuropsychological Status total scaled score. The scaled score is age adjusted with a mean of 100 and a standard deviation of 15. Scores below 100 indicate poorer cognitive function relative to same-age peers.

    Measured: 2 weeks, 3, 6, and 12 months

  3. Sleep quality

    Sleep duration in hours obtained from averaging values from participant's 1-week sleep diary. Healthy sleep duration for older adults ranges between 7-8 hours per night.

    Measured: 2 weeks, 3, 6, and 12 months

  4. Psychological function

    Geriatric depression scale, 15-item version. Range 0-15 with higher scores indicating more severe symptoms of depression.

    Measured: 2 weeks, 3, 6, and 12 months

Secondary outcomes (9)
  1. Physical Function

    The Four-Step Square Test, measured as the number of seconds needed to complete the test. Values greater than 15 seconds are associated with increased fall risk.

    Measured: 2 weeks, 3, 6, and 12 months

  2. Physical Function

    Activities of Daily Living, range 0-6 with higher scores indicating increased independence in activities of daily living

    Measured: 2 weeks, 3, 6, and 12 months

  3. Physical Function

    Instrumental Activities of Daily Living, range 0-8 with higher scores indicating independence in instrumental activities of daily living

    Measured: 2 weeks, 3, 6, and 12 months

  4. Physical Function

    Glasgow Outcomes Scale Extended, range 1-8 with higher scores indicating better recovery following traumatic brain injury

    Measured: 2 weeks, 3, 6, and 12 months

  5. Cognition

    Repeatable Battery for the Assessment of Neuropsychological Status domain scores (delayed memory, immediate memory, visuo-spatial, language, attention). The scaled score is age adjusted with a mean of 100 and a standard deviation of 15. Scores below 100 indicate poorer cognitive function relative to same-age peers

    Measured: 2 weeks, 3, 6, and 12 months

  6. Sleep Quality

    Insomnia Severity Index, range 0-28 with higher scores indicating increased symptoms of insomnia

    Measured: 2 weeks, 3, 6, and 12 months

  7. Sleep Quality

    Pittsburgh Sleep Quality Index, range 0-21 with higher scores indicating poorer sleep quality

    Measured: 2 weeks, 3, 6, and 12 months

  8. Psychological Function

    Hospital Anxiety and Depression Scale (anxiety sub-scale), range 0-21 with higher scores indicating increased symptoms of anxiety

    Measured: 2 weeks, 3, 6, and 12 months

  9. Psychological Function

    Rivermead post-concussion symptoms questionnaire, range 0-64 with higher scores indicating more severe post-concussive symptoms.

    Measured: 2 weeks, 3, 6, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2026
  2. Study start11 May 2023
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07569354
Sponsor's protocol ID
HP-00100973
Other IDs
R01AG076441
Status last verified
Apr 2026
First submitted
1 Apr 2026
Last updated
6 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified data from RETRO-TBI will be shared with eligible researchers after completion of study aims upon approval of a proposal including an analytic plan. Interested researchers should contact the PI for additional information.

Questions about this trial

What is this clinical trial studying?

An observational study of Mild Traumatic Brain Injury, run by University of Maryland, Baltimore 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 6 May 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jennifer Albrecht, PhD (410-706-0071 ext. 410-706-0071, jalbrecht@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical function (time frame: 2 weeks, 3, 6, and 12 months). The study lists 4 primary outcomes in all. 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 6 May 2026.

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