Recovery Trajectory for Coma and Disorders of Consciousness
Part of paid clinical trials in San Francisco, California.
- Sponsor
- University of California, San Francisco
- Study ID
- NCT07614074
- Status
- Recruiting
Conditions
- Cardiac Arrest (CA)
- Coma
- Disorders of Consciousness
- Hemorrhagic Stroke, Intracerebral
- Ischemic Stroke
- Meningitis/Encephalitis
- Status Epilepticus
- Traumatic Brain Injuries
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Study Details
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.
Key Dates
- Start date
- Sep 26, 2023
- Status verified
- May 2026
- Primary completion
- Sep 30, 2033
- Completion
- Sep 30, 2033
Study Design
- Enrollment
- 2,000 participants (estimated)
Arms
- Arm: Adults with Disorders of Consciousness from Acute Neurologic InjuryAdults hospitalized with coma or disorders of consciousness due to acute neurologic injury or illness, including conditions such as ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage, traumatic brain injury, cardiac arrest with hypoxic-ischemic brain injury, status epilepticus, central nervous system infection, toxic-metabolic encephalopathy, and other acute neurologic etiologies. Participants are enrolled during hospitalization and followed longitudinally after discharge to assess functional recovery, quality of life, emotional well-being, and other patient-centered outcomes. No intervention is assigned as part of study participation.
Primary Outcome Measure
Modified Rankin Scale (mRS) [ Time Frame: 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, and 48 months after coma onset, with continued assessments at 6-month intervals thereafter until study completion ]
Central Contacts
- Claude Hemphill, MD, MAS415-476-5100
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Zuckerberg San Francisco General Hospital and Trauma Center | San Francisco | California | 94110 | Claude Hemphill, MD, MAS (PRINCIPAL_INVESTIGATOR) |
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