Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT07614074

Conditions

Coma

Disorders of Consciousness

Cardiac Arrest (CA)

Traumatic Brain Injuries

Ischemic Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Coma

Disorders of Consciousness

Cardiac Arrest (CA)

Traumatic Brain Injuries

Ischemic Stroke

Study ID

NCT07614074

Start date

Sep 26, 2023

Status verified date

May, 2026

Completion date

Sep, 2033

Anticipated

Primary completion date

Sep, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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 and Locations

Central contacts

Claude Hemphill, MD, MAS

415-476-5100claude.hemphill@ucsf.edu

Locations

Zuckerberg San Francisco General Hospital and Trauma Center

Recruiting

San Francisco, California, United States, 94110

Contacts

Derby Gill, BS, MS

415-476-5101derby.gill@ucsf.edu

Principal Investigator:

Claude Hemphill, MD, MAS

More Information

Sponsor

University of California, San Francisco

Last update posted

Jun 2, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-06-02.