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| Name | Class |
|---|---|
| Zuckerberg San Francisco General Hospital and Trauma Center | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults with Disorders of Consciousness from Acute Neurologic Injury | Adults 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin Scale (mRS) | Functional outcome will be assessed using the modified Rankin Scale, a clinician-administered measure of global disability following neurologic injury. Scores range from 0 to 6, with higher scores indicating greater disability. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Glasgow Outcome Scale Extended (GOSE) | Global functional recovery will be assessed using the Glasgow Outcome Scale Extended, a validated measure of disability and recovery after severe neurologic injury. Scores range from 1 to 8, with higher scores indicating better functional recovery. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Hospitalized adult patients with coma or disorders of consciousness resulting from acute neurologic injury or illness.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claude Hemphill, MD, MAS | Contact | 415-476-5100 | claude.hemphill@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Claude Hemphill, MD, MAS | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuckerberg San Francisco General Hospital and Trauma Center | Recruiting | San Francisco | California | 94110 | United States |
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| ID | Term |
|---|---|
| D003128 | Coma |
| D003244 | Consciousness Disorders |
| D006323 | Heart Arrest |
| D000070642 | Brain Injuries, Traumatic |
| D000083242 | Ischemic Stroke |
| D000083302 | Hemorrhagic Stroke |
| D008581 | Meningitis |
| D004660 | Encephalitis |
| D013226 | Status Epilepticus |
| ID | Term |
|---|---|
| D014474 | Unconsciousness |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| EuroQol Five-Dimension Questionnaire (EQ-5D) | Health-related quality of life will be assessed using the EuroQol Five-Dimension Questionnaire, a validated patient-reported measure evaluating mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. | 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 |
| Social Determinants of Health Questionnaire | Social and environmental factors including housing stability, access to healthcare, social support, transportation, and other relevant social determinants of health, will be assessed using a structured questionnaire. | 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 |
| Patient Health Questionnaire-8 (PHQ-8) | Depressive symptoms will be assessed using the Patient Health Questionnaire-8, a validated self-reported screening measure for depression. Higher scores indicate greater depressive symptom burden. | 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 |
| Generalized Anxiety Disorder-7 (GAD-7) | Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 questionnaire, a validated self-reported measure of anxiety symptom severity. Higher scores indicate greater anxiety symptom burden. | 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 |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D012640 | Seizures |