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NCT Number: NCT05682248

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

The research focuses on establishing a system for validating the effectiveness of key technologies for targeted combined non-invasive interventions in awakening consciousness.

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Key information

Conditions

Disorder of Consciousness Consciousness Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

14 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xuan Wu hospitial, capical medical university

Beijing, China

About this study

Analyzed the EEG activity and brain network changes before and after stimulation by TMS stimulation of key brain regions, and correlated them with brain function. To verify the "time-frequency-space" neural mechanism of consciousness.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Admission criteria for patients with prolonged disorders of consciousness (Total 200) Inclusion Criteria:(1)Age 14-80 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(Total 300) 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;

Treatment and study plan

Transcranial Magnetic Stimulation

Device

Transcranial magnetic stimulation

Sham Transcranial Magnetic Stimulation

Device

Sham Transcranial magnetic stimulation

Primary outcomes

  1. Change from Coma recovery scale-revised（CRS-R）

    Time frame: Assessment within 24 hours before, and 1 hour after TMS treatment

    CRS-R scale includes 6 dimensions such as audiovisual, arousal level, verbal response, motor and communication, scoring 0 to 23, the higher the score the better the neurological function, and each score reflects the presence or absence of the evaluated person and the strength of consciousness

  2. Change from the p300 in electroencephalogram

    Time frame: Assessment within 24 hours before, and 1 hour after TMS treatment

    Assessment the p300 in event related potential(ERP)

  3. Change from resting-state in electroencephalogram

    Time frame: Assessment within 24 hours before, and 1 hour after TMS treatment

    Assessment the spectral power and coherence by in resting-state EEG

  4. Change from TEP in electroencephalogram

    Time frame: Assessment within 24 hours before, and 1 hour after TMS treatment

    Assessment the TMS Evoked Potential(TEP)

  5. Change from PCI in electroencephalogram

    Time frame: Assessment within 24 hours before, and 1 hour after TMS treatment

    Assessment the perturbational complexity index(PCI) in TMS-EEG

  6. Change from ROI in neuroimage techniques-PET

    Time frame: Assessment within 24 hours before ,and 1 hour after TMS treatment

    The distribution of 18F-FDG in the brain was analyzed according to the imaging situation, and the brain regions of interest (ROI) were outlined, and the uptake of 18F-deoxyglucose (FDG) in the patients was observed according to the brain ROI.

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Collaborators

  • Jilin University
  • Tianjin University

Registry information

Official study title

Science and Technology Innovation 2030

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Jan 12, 2023
Registry last updated
Jun 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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