This study is being done to learn how information from blood tests, medical records, and wearable devices that track sleep, activity, and heart rate can help predict how people recover after a concussion. The goal is to improve how doctors monitor recovery and give patients better information about what to expect after a head injury.
Diagnosis of mild traumatic brain injury (TBI), as defined by the 2023 American Congress of Rehabilitation Medicine (ACRM) criteria.
Enrollment within 24 hours of injury.
Glasgow Coma Scale (GCS) score of 15 at emergency department (ED) enrollment.
Blood collection for biomarker measurement, including glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase L1 (UCH-L1).
Pre-existing neurological disability or pre-injury condition that would have resulted in a Glasgow Outcome Scale-Extended (GOS-E) score <8 if assessed before the injury.
High risk of loss to follow-up, including patients without a reliable phone, those experiencing homelessness, those who are incarcerated, or those who are wards of the state.
Pregnancy at the time of enrollment.
Inability to speak English or Spanish, which would prevent completion of the required assessments.
Adult patients aged 18 to 65 years at the time of enrollment who present to participating emergency departments (EDs) with suspected traumatic brain injury (TBI) meeting the 2023 American Congress of Rehabilitation Medicine (ACRM) criteria and a Glasgow Coma Scale (GCS) score of 15. Key exclusion criteria include pre-existing neurological disability resulting in a pre-injury Glasgow Outcome Scale-Extended (GOS-E) score \<8, high risk of loss to follow-up (e.g., no reliable phone, homelessness, incarceration, or ward of the state), pregnancy, and inability to speak English or Spanish
Cohort
Prospective
Not listed
Functional recovery
Functional recovery will be assessed using the Glasgow Outcome Scale-Extended (GOS-E). The GOS-E rates patient status on one of eight levels. The minimum score is 1 and the maximum score is 8: 1 = death; 2 = vegetative state; 3 = lower severe disability; 4 = upper severe disability; 5 = lower moderate disability; 6 = upper moderate disability; 7 = lower good recovery; and 8 = upper good recovery.
Daily symptom burden
Daily symptom burden will be measured using five commonly endorsed items-fatigue, headache, poor concentration, frustration, and sleep problems-from the Rivermead Post-Concussion Questionnaire (RPQ), a validated instrument that assesses post-concussive symptom severity. Each symptom is rated from 0 to 4, with 0 indicating that the symptom is not experienced and 4 indicating a severe problem. Scores for the five items are summed to yield a total score ranging from 0 to 20, with higher scores indicating greater daily post-concussive symptom burden.
Heart rate variability (HRV)
HRV will be continuously measured using the WHOOP wearable device. HRV will be reported in milliseconds (ms) and reflects variation in the time intervals between successive heartbeats. HRV is a continuous physiological measure with no predefined minimum or maximum value. Higher or lower HRV values are not inherently classified as better or worse outcomes; values will be evaluated as physiological measures in relation to recovery following traumatic brain injury.
Resting heart rate (rHR)
Physiological outcomes will be continuously measured via the WHOOP wearable device. WHOOP is a wearable health and fitness tracker that continuously monitors key physiological metrics
Sleep patterns - Sleep duration
Sleep duration will be continuously measured using the WHOOP wearable device. WHOOP is a wearable health and fitness tracker that continuously monitors key physiological metrics.
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University of Michigan
Lead sponsor
Congressionally Directed Medical Research Programs
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
