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NCT Number: NCT07569354

Recovery Among Older Adults Following Mild TBI

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location status: Recruiting

Location contact

Jennifer Albrecht, PhD

CONTACT

[email protected]

410-706-0071 ext. 410-706-0071

Jennifer Albrecht, PhD

PRINCIPAL_INVESTIGATOR

Michelle Newman, BSN

CONTACT

[email protected]

410-706-0933 ext. 410-706-0071

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Physical function

    Time frame: 2 weeks, 3, 6, and 12 months

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

  2. Cognition

    Time frame: 2 weeks, 3, 6, and 12 months

    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.

  3. Sleep quality

    Time frame: 2 weeks, 3, 6, and 12 months

    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.

  4. Psychological function

    Time frame: 2 weeks, 3, 6, and 12 months

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

Secondary outcomes

  1. Physical Function

    Time frame: 2 weeks, 3, 6, and 12 months

    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.

  2. Physical Function

    Time frame: 2 weeks, 3, 6, and 12 months

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

  3. Physical Function

    Time frame: 2 weeks, 3, 6, and 12 months

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

  4. Physical Function

    Time frame: 2 weeks, 3, 6, and 12 months

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

  5. Cognition

    Time frame: 2 weeks, 3, 6, and 12 months

    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

  6. Sleep Quality

    Time frame: 2 weeks, 3, 6, and 12 months

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

  7. Sleep Quality

    Time frame: 2 weeks, 3, 6, and 12 months

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

  8. Psychological Function

    Time frame: 2 weeks, 3, 6, and 12 months

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

  9. Psychological Function

    Time frame: 2 weeks, 3, 6, and 12 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Albrecht, PhD

CONTACT

[email protected]

410-706-0071 ext. 410-706-0071

Michelle Newman, BSN

CONTACT

[email protected]

410-706-0933

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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