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RecruitingNCT07614074Coma CohortUpdated Jun 2, 2026

Recovery Trajectory for Coma and Disorders of Consciousness

An observational study in Coma, Disorders of Consciousness and Cardiac Arrest (CA), sponsored by University of California, San Francisco. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-02.

Sponsored by University of California, San Francisco · Observational

From the registry’s dates

  • Started Sep 2023; still recruiting 3 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Coma
  • Disorders of Consciousness
  • Cardiac Arrest (CA)
  • Traumatic Brain Injuries
  • Ischemic Stroke
  • Hemorrhagic Stroke, Intracerebral
  • Meningitis/Encephalitis
  • Status Epilepticus
03

In context

Coma

138 studies on the registry are indexed under Coma; 35 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 100 across 58 observational studies indexed under Coma.

Browse Coma studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

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.

    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

Secondary outcomes

  1. 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.

    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

  2. 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.

    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

  3. 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.

    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

  4. 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.

    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

  5. 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.

    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

07

Study locations

1 of 1 sites recruiting
  • Zuckerberg San Francisco General Hospital and Trauma Center
    San Francisco, California 94110, United States
    Recruiting
    • Derby Gill, BS, MS · Contactderby.gill@ucsf.edu · 415-476-5101
    • Claude Hemphill, MD, MAS · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07614074
Collaborators
Zuckerberg San Francisco General Hospital and Trauma Center
Responsible party
Sponsor
First posted
May 29, 2026
Start date
Sep 26, 2023
Primary completion
Sep 2033 (estimated)
Completion
Sep 2033 (estimated)
Last update
Jun 2, 2026

Study contacts

Claude Hemphill, MD, MAS
Contact
claude.hemphill@ucsf.edu
415-476-5100
Claude Hemphill, MD, MAS
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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