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

20. maj 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

2000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • California
      • San Francisco, California, Forenede Stater, 94110
        • Rekruttering
        • Zuckerberg San Francisco General Hospital and Trauma Center
        • Kontakt:
        • Ledende efterforsker:
          • Claude Hemphill, MD, MAS

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Modified Rankin Scale (mRS)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Glasgow Outcome Scale Extended (GOSE)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of California, San Francisco

Samarbejdspartnere

Zuckerberg San Francisco General Hospital and Trauma Center

Efterforskere

  • Ledende efterforsker: Claude Hemphill, MD, MAS, University of California, San Francisco

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

26. september 2023

Primær færdiggørelse (Anslået)

1. september 2033

Studieafslutning (Anslået)

1. september 2033

Datoer for studieregistrering

Først indsendt

20. maj 2026

Først indsendt, der opfyldte QC-kriterier

20. maj 2026

Først opslået (Faktiske)

29. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 22-36824

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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