Recovery Trajectory for Coma and Disorders of Consciousness

NCT07614074 | Recruiting

• 1 other identifier: 22-36824
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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; Hemorrhagic Stroke, Intracerebral; Meningitis/Encephalitis; Status Epilepticus

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Glasgow Outcome Scale Extended (GOSE)

  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

• EuroQol Five-Dimension Questionnaire (EQ-5D)

  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

  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)

  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)

  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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized adult patients with coma or disorders of consciousness resulting from acute neurologic injury or illness.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Zuckerberg San Francisco General Hospital and Trauma Center: collaborator

Study Sites (1)

Zuckerberg San Francisco General Hospital and Trauma Center

San Francisco, California, 94110, United States

RECRUITING

MeSH Terms

Conditions

Coma; Consciousness Disorders; Heart Arrest; Brain Injuries, Traumatic; Ischemic Stroke; Hemorrhagic Stroke; Meningitis; Encephalitis; Status Epilepticus

Condition Hierarchy (Ancestors)

Unconsciousness; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Heart Diseases; Cardiovascular Diseases; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Stroke; Cerebrovascular Disorders; Vascular Diseases; Neuroinflammatory Diseases; Seizures

Study Officials

• Claude Hemphill, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claude Hemphill, MD, MAS

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 29, 2026
• Study Start: September 26, 2023
• Primary Completion (Estimated): September 1, 2033
• Study Completion (Estimated): September 1, 2033
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)