Study of Brain Function Evaluation and Intervention System for Acute and Prolonged Disorders 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: Transcranial magnetic stimulation, Sham Transcranial magnetic stimulation.
- Who it may be relevant to
- Registry conditions: Disorder of Consciousness. Basic parameters: 14 years — 80 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 validating the effectiveness of key technologies for targeted combined non-invasive interventions in awakening consciousness.
Detailed description
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.
Interventions
- Device Transcranial magnetic stimulation
Transcranial magnetic stimulation - Device Sham Transcranial magnetic stimulation
Sham Transcranial magnetic stimulation
Primary outcome measures
- Change from Coma recovery scale-revised（CRS-R） [Time frame: Assessment within 24 hours before, and 1 hour after TMS treatment]
- 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]
- 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 (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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Xuan Wu hospitial, capical medical university — Beijing
Identifiers
NCT: NCT05682248 · 2021ZD0204305