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

28 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Type d'étude

Observationnel

Inscription (Estimé)

2000

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Nom: Claude Hemphill, MD, MAS
Numéro de téléphone: 415-476-5100
E-mail: claude.hemphill@ucsf.edu

Lieux d'étude

États-Unis
- California
  - San Francisco, California, États-Unis, 94110
    - Recrutement
    - Zuckerberg San Francisco General Hospital and Trauma Center
    - Contact:
      
      Derby Gill, BS, MS
      
      Numéro de téléphone: 415-476-5101
      
      E-mail: derby.gill@ucsf.edu
    - Chercheur principal:
      
      Claude Hemphill, MD, MAS

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Adulte
Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
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.

Groupe / Cohorte

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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Modified Rankin Scale (mRS) Délai: 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.	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

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Glasgow Outcome Scale Extended (GOSE) Délai: 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.	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) Délai: 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.	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 Délai: 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.	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) Délai: 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.	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) Délai: 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.	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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of California, San Francisco

Collaborateurs

Zuckerberg San Francisco General Hospital and Trauma Center

Les enquêteurs

Chercheur principal: Claude Hemphill, MD, MAS, University of California, San Francisco

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

26 septembre 2023

Achèvement primaire (Estimé)

1 septembre 2033

Achèvement de l'étude (Estimé)

1 septembre 2033

Dates d'inscription aux études

Première soumission

20 mai 2026

Première soumission répondant aux critères de contrôle qualité