Recovery Among Older Adults Following Mild TBI

NCT07569354 | Recruiting

• 2 other identifiers: HP-00100973R01AG076441
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Mild Traumatic Brain Injury

Keywords

TBI; Older adults

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• Physical Function

  2 weeks, 3, 6, and 12 months

• Physical Function

  2 weeks, 3, 6, and 12 months

• Physical Function

  2 weeks, 3, 6, and 12 months

• Physical Function

  2 weeks, 3, 6, and 12 months

• Cognition

  2 weeks, 3, 6, and 12 months

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood plasma

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Jennifer Albrecht, PhD

  University of Maryland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Albrecht, PhD

CONTACT

410-706-0071; jalbrecht@som.umaryland.edu

Michelle Newman, BSN

CONTACT

410-706-0933; mnewman@som.umaryland.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: May 6, 2026
• Study Start: May 11, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Start Date: 1/1/31. No end date.
• 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.

Locations

US (1)