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Enrolling by invitation NCT06097013

Study of Brain Function Evaluation System for Acute and Prolonged Disorders of Consciousness

— Observational Disorder of Consciousness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Routine clinical rehabilitation.
Who it may be relevant to
Registry conditions: Disorder of Consciousness. Basic parameters: 14 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Science and Technology Innovation 2030

Overview

The research focuses on establishing a system for detecting loss of consciousness, developing clinical prognostic and awakening-related brain function testing criteria.

Detailed description

A framework for the acquisition of neural features, feature selection and mechanism analysis of consciousness deficits in patients with acute and prolonged disorders of consciousness(DOC). Based on the multimodal data of three types of patients with DOC, the investigators established a comprehensive scientific collection of brain function features of acute and prolonged consciousness disorders; Revealed the key neural nodes and circuits of consciousness deficits, and elucidated the neural mechanisms of consciousness deficits in patients with prolonged consciousness disorders from EEG time-frequency-spatial features;

Interventions

  • Other Routine clinical rehabilitation
    Routine clinical rehabilitation

Primary outcome measures

  • Change from Coma recovery scale-revised [Time frame: Within 24 hours of enrollment]
  • Change from the p300 in electroencephalogram [Time frame: Assessment within 24 hours before, and 1 hour after TMS treatment]
  • Change from resting-state in electroencephalogram [Time frame: Assessment within 24 hours before, and 1 hour after TMS treatment]
  • Change from TEP in electroencephalogram [Time frame: Assessment within 24 hours before, and 1 hour after TMS treatment]
  • Change from PCI in electroencephalogram [Time frame: Assessment within 24 hours before, and 1 hour after TMS treatment]
Secondary outcome measures (1)
  • Change from ROI in neuroimage techniques-PET [Time frame: Assessment within 24 hours before ,and 1 hour after TMS treatment]

Eligibility criteria

Admission criteria for patients with prolonged disorders of consciousness

Inclusion criteria

  • Age 14-60 years;
  • In accordance with the diagnostic criteria of unresponsive arousal syndrome or minimally conscious state by international research;
  • Brain Trauma, stroke and hypoxic-ischemic encephalopathy lead to disturbance of consciousness;
  • right-handed；
  • The patient's family members signed the informed consent form;

Exclusion criteria

  • The history of mental illness and a history of hearing impairment;
  • Intracranial arterial clamp, pacemaker and other metal implants;
  • During the experiment, sedatives and other drugs that affect the excitability of the cortex;
  • The presence of uncontrolled seizures or involuntary movements;

Admission criteria for patients with acute disorders of consciousness

Inclusion criteria

(1)Age 14-60 years; (2）Meets diagnostic criteria for coma recognized in international studies； (3)the GCS score was less than 8; (4)Brain Trauma, stroke and hypoxic-ischemic encephalopathy lead to disturbance of consciousness; (5) right-handed； (6)The patient's family members signed the informed consent form;

Exclusion criteria

  • The history of mental illness and a history of hearing impairment;
  • Intracranial arterial clamp, pacemaker and other metal implants;
  • During the experiment, sedatives and other drugs that affect the excitability of the cortex;
  • The presence of uncontrolled seizures or involuntary movements; Admission criteria for patients with acute disorders of consciousness;
  • No spontaneous breathing;
  • Status Epilepticus;
  • Need emergency neurosurgical treatment can not cooperate with the examination;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Xuan Wu hospitial, capical medical university — Beijing

Identifiers

NCT: NCT06097013 · 2021ZD0204300

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗