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.

Study Overview

• Status: Recruiting
• Conditions: Mild Traumatic Brain Injury

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.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Jennifer Albrecht, PhD; Phone Number: 410-706-0071 410-706-0071; Email: jalbrecht@som.umaryland.edu
• Study Contact Backup: Name: Michelle Newman, BSN; Phone Number: 410-706-0933; Email: mnewman@som.umaryland.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland, Baltimore
      • Contact: Jennifer Albrecht, PhD; Phone Number: 410-706-0071 410-706-0071; Email: jalbrecht@som.umaryland.edu
      • Contact: Michelle Newman, BSN; Phone Number: 410-706-0071 410-706-0933; Email: mnewman@som.umaryland.edu
      • Principal Investigator: Jennifer Albrecht, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical function	Short Physical Performance Battery total score. Range 0-12, Higher scores indicating better lower extremity function	2 weeks, 3, 6, and 12 months
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.	2 weeks, 3, 6, and 12 months
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.	2 weeks, 3, 6, and 12 months
Psychological function	Geriatric depression scale, 15-item version. Range 0-15 with higher scores indicating more severe symptoms of depression.	2 weeks, 3, 6, and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 weeks, 3, 6, and 12 months
Physical Function	Activities of Daily Living, range 0-6 with higher scores indicating increased independence in activities of daily living	2 weeks, 3, 6, and 12 months
Physical Function	Instrumental Activities of Daily Living, range 0-8 with higher scores indicating independence in instrumental activities of daily living	2 weeks, 3, 6, and 12 months
Physical Function	Glasgow Outcomes Scale Extended, range 1-8 with higher scores indicating better recovery following traumatic brain injury	2 weeks, 3, 6, and 12 months
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	2 weeks, 3, 6, and 12 months
Sleep Quality	Insomnia Severity Index, range 0-28 with higher scores indicating increased symptoms of insomnia	2 weeks, 3, 6, and 12 months
Sleep Quality	Pittsburgh Sleep Quality Index, range 0-21 with higher scores indicating poorer sleep quality	2 weeks, 3, 6, and 12 months
Psychological Function	Hospital Anxiety and Depression Scale (anxiety sub-scale), range 0-21 with higher scores indicating increased symptoms of anxiety	2 weeks, 3, 6, and 12 months
Psychological Function	Rivermead post-concussion symptoms questionnaire, range 0-64 with higher scores indicating more severe post-concussive symptoms.	2 weeks, 3, 6, and 12 months

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Jennifer Albrecht, PhD, University of Maryland

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: April 1, 2026
• First Submitted That Met QC Criteria: April 28, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: TBI; Older adults
• Additional Relevant MeSH Terms: Brain Injuries, Traumatic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Concussion
• Other Study ID Numbers: HP-00100973; R01AG076441 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Start Date: 1/1/31. No end date.
• IPD Sharing Access Criteria: Interested researchers should contact the PI after the availability date and will be asked to submit a proposal for use of the data including an analytic plan.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No