Recovery Trajectory for Coma and Disorders of Consciousness (Coma Cohort)

May 20, 2026 updated by: University of California, San Francisco

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • Recruiting
        • Zuckerberg San Francisco General Hospital and Trauma Center
        • Contact:
        • Principal Investigator:
          • Claude Hemphill, MD, MAS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Rankin Scale (mRS)
Time Frame: 1 month after coma onset, every 3 months through 24 months, and every 6 months thereafter
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 month after coma onset, every 3 months through 24 months, and every 6 months thereafter

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glasgow Outcome Scale Extended (GOSE)
Time Frame: 1 month after coma onset, every 3 months through 24 months, and every 6 months thereafter
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 month after coma onset, every 3 months through 24 months, and every 6 months thereafter
EuroQol Five-Dimension Questionnaire (EQ-5D)
Time Frame: 1 month after coma onset, every 3 months through 24 months, and every 6 months thereafter
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 month after coma onset, every 3 months through 24 months, and every 6 months thereafter
Social Determinants of Health Questionnaire
Time Frame: 1 month after coma onset, every 3 months through 24 months, and every 6 months thereafter
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 month after coma onset, every 3 months through 24 months, and every 6 months thereafter
Patient Health Questionnaire-8 (PHQ-8)
Time Frame: 1 month after coma onset, every 3 months through 24 months, and every 6 months thereafter
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 month after coma onset, every 3 months through 24 months, and every 6 months thereafter
Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: 1 month after coma onset, every 3 months through 24 months, and every 6 months thereafter
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 month after coma onset, every 3 months through 24 months, and every 6 months thereafter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Zuckerberg San Francisco General Hospital and Trauma Center

Investigators

  • Principal Investigator: Claude Hemphill, MD, MAS, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2023

Primary Completion (Estimated)

September 1, 2033

Study Completion (Estimated)

September 1, 2033

Study Registration Dates

First Submitted

May 20, 2026

First Submitted That Met QC Criteria

May 20, 2026

First Posted (Actual)

May 29, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-36824

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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