NCT07569354 Recovery Among Older Adults Following Mild TBI
| NCT ID | NCT07569354 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Maryland, Baltimore |
| Condition | Mild Traumatic Brain Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2023-05-11 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2023-05-11 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Jennifer Albrecht, PhD
PRINCIPAL INVESTIGATOR
University of Maryland
Frequently Asked Questions
Who can join the NCT07569354 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Mild Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07569354 currently recruiting?
Yes, NCT07569354 is actively recruiting participants. Contact the research team at jalbrecht@som.umaryland.edu for enrollment information.
Where is the NCT07569354 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT07569354 clinical trial?
NCT07569354 is sponsored by University of Maryland, Baltimore. The principal investigator is Jennifer Albrecht, PhD at University of Maryland. The trial plans to enroll 250 participants.