ComaComa CohortNCT07614074
Recovery Trajectory for Coma and Disorders of Consciousness
An observational study of Coma and Disorders of Consciousness, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coma, Disorders of Consciousness, Cardiac Arrest (CA)
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2023to Sep 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized adult patients with coma or disorders of consciousness resulting from acute neurologic injury or illness.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, 94110
Derby Gill, BS, MS, 415-476-5101, derby.gill@ucsf.edu
Claude Hemphill, MD, MAS
About this study
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.
Read more
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
- Medical subject headings
- Coma, Consciousness Disorders, Heart Arrest, Brain Injuries, Traumatic, Ischemic Stroke, Hemorrhagic Stroke, Meningitis, Encephalitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start26 Sep 2023
- Primary completionSep 2033 (estimated)
- Study completionSep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Zuckerberg San Francisco General Hospital and Trauma Center
- Responsible party
- Sponsor
- Investigators
- Claude Hemphill, MD, MAS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614074
- Sponsor's protocol ID
- 22-36824
- Acronym
- Coma Cohort
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery Trajectory for Coma and Disorders of Consciousness
- ClinicalTrials.gov ID
- NCT07614074
- Acronym / sponsor ID
- Coma Cohort / 22-36824
- Conditions
- Coma, Disorders of Consciousness, Cardiac Arrest (CA), Traumatic Brain Injuries, Ischemic Stroke, Hemorrhagic Stroke, Intracerebral
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Zuckerberg San Francisco General Hospital and Trauma Center
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- Sep 2033 (estimated)
- Study completion
- Sep 2033 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized adult patients with coma or disorders of consciousness resulting from acute neurologic injury or illness.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claude Hemphill, MD, MAS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coma and Disorders of Consciousness, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claude Hemphill, MD, MAS (415-476-5100, claude.hemphill@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.