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

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Capital Medical University

Status

Invitation-only

Conditions

Disorder of Consciousness

Treatments

Other: Routine clinical rehabilitation

Study type

Observational

Funder types

Other

Identifiers

NCT06097013
2021ZD0204300

Details and patient eligibility

About

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

Full 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;

Enrollment

500 estimated patients

Sex

All

Ages

14 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Admission criteria for patients with prolonged disorders of consciousness

Inclusion Criteria:

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

Exclusion Criteria:

  1. The history of mental illness and a history of hearing impairment;
  2. Intracranial arterial clamp, pacemaker and other metal implants;
  3. During the experiment, sedatives and other drugs that affect the excitability of the cortex;
  4. 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:

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

Trial design

500 participants in 2 patient groups

Prolonged disorders of consciousness
Description:
Admission criteria for patients with prolonged disorders of consciousness Inclusion Criteria
Treatment:
Other: Routine clinical rehabilitation
Acute disorders of consciousness
Description:
Admission criteria for patients with acute disorders of consciousness Inclusion Criteria
Treatment:
Other: Routine clinical rehabilitation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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