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NCT Number: NCT07614074

Recovery Trajectory for Coma and Disorders of Consciousness

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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Key information

Conditions

Coma Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiac Arrest (CA) Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Consciousness Disorders Craniocerebral Trauma Disorders of Consciousness Encephalitis Heart Arrest Heart Diseases Hemorrhagic Stroke Hemorrhagic Stroke, Intracerebral Ischemic Stroke Meningitis Meningitis/Encephalitis Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neuroinflammatory Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms Status Epilepticus Stroke Trauma, Nervous System Traumatic Brain Injuries Unconsciousness Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zuckerberg San Francisco General Hospital and Trauma Center

San Francisco, California, 94110, United States

Location status: Recruiting

Location contact

Claude Hemphill, MD, MAS

PRINCIPAL_INVESTIGATOR

Derby Gill, BS, MS

CONTACT

[email protected]

415-476-5101

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. Glasgow Outcome Scale Extended (GOSE)

    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

    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.

  2. EuroQol Five-Dimension Questionnaire (EQ-5D)

    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

    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.

  3. Social Determinants of Health Questionnaire

    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

    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.

  4. Patient Health Questionnaire-8 (PHQ-8)

    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

    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.

  5. Generalized Anxiety Disorder-7 (GAD-7)

    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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Claude Hemphill, MD, MAS

CONTACT

[email protected]

415-476-5100

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Zuckerberg San Francisco General Hospital and Trauma Center

Registry information

Acronym: Coma Cohort

Important dates

Study start
2023
Primary completion
2033
Study completion
2033
First posted
May 29, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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