Recruiting

Observational Study

Sponsor:

University of Maryland, Baltimore

Code:

NCT07569354

Conditions

Mild Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT07569354

Start date

May 11, 2023

Status verified date

Apr, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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 Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Physical function [ Time Frame: 2 weeks, 3, 6, and 12 months ]
  • Cognition [ Time Frame: 2 weeks, 3, 6, and 12 months ]
  • Sleep quality [ Time Frame: 2 weeks, 3, 6, and 12 months ]
  • Psychological function [ Time Frame: 2 weeks, 3, 6, and 12 months ]

Central Contacts and Locations

Central contacts

Jennifer Albrecht, PhD

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

Michelle Newman, BSN

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

Locations

University of Maryland, Baltimore

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Michelle Newman, BSN

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

Jennifer Albrecht, PhD

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

Principal Investigator:

Jennifer Albrecht, PhD

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

May 6, 2026

Last verified

Apr, 2026

Keywords

  • TBI
  • Older adults

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-05-06.