NCT07614074 Recovery Trajectory for Coma and Disorders of Consciousness
| NCT ID | NCT07614074 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Coma |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2023-09-26 |
| Primary Completion | 2033-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 2,000 participants in total. It began in 2023-09-26 with a primary completion date of 2033-09.
⚠ 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
This study aims to better understand recovery after coma caused by serious neurologic illness or injury. Patients who are unconscious (in a coma or disorder of consciousness) due to conditions such as stroke, cardiac arrest, traumatic brain injury, seizures, brain infection, or other neurologic emergencies may be enrolled during their hospitalization. The purpose of this observational research study is to learn which medical, neurologic, psychological, and social factors are associated with recovery over time. Researchers will collect information from the medical record during hospitalization, including details about the patient's illness, treatments received, brain imaging, and neurologic examinations. For patients who survive hospitalization, the study team will contact participants or their caregivers after discharge to assess recovery at scheduled time points using questionnaires and structured interviews about physical function, quality of life, emotional well-being, and daily activities. This study does not assign participants to any experimental treatment. Participation will not change the medical care patients receive. Information learned from this study may help improve future care for patients with coma and disorders of consciousness.
Eligibility Criteria
Inclusion Criteria: * Age greater than or equal to 18 years on the day of hospital admission * Coma duration of at least 24 hours from presentation to the receiving hospital, or died prior to the 24 hour timepoint without return of consciousness. Coma defined as: GCS score of less than or equal to 10 AND GCS score of less than 6 on the motor component of the GCS(not following commands) AND GCS score less than 3 on the verbal component AND alteration of consciousness not explained by sedation only * Coma due to a neurological process (Including but not limited to: trauma, stroke, hypoxic- ischemic brain injury (HIBI), CNS infection, seizure, other processes at the discretion of the investigator) * Admission to the intensive care unit, or deceased prior to admission. Exclusion Criteria: * Pre-existing score of 5 or less on the motor component of the Glasgow Coma Scale prior to hospital admission. * Transfer from another acute care hospital in which the motor component of the Glasgow Coma Scale on the day after initial hospital arrival is not known or cannot be reconstructed from medical records or history. * Coma due to sepsis, systemic metabolic processes (ex: organ failure or sedation). * GCS score of greater than 2 for eye opening with lack of command following due to a focal brain lesion causing receptive aphasia. * Prisoner
Contact & Investigator
Claude Hemphill, MD, MAS
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT07614074 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07614074 currently recruiting?
Yes, NCT07614074 is actively recruiting participants. Contact the research team at claude.hemphill@ucsf.edu for enrollment information.
Where is the NCT07614074 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT07614074 clinical trial?
NCT07614074 is sponsored by University of California, San Francisco. The principal investigator is Claude Hemphill, MD, MAS at University of California, San Francisco. The trial plans to enroll 2,000 participants.