Disorder of Consciousness
Conditions
Keywords
TMS, Non-invasive neuromodulation, Brain Function Test
Brief summary
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
DEVICETranscranial magnetic stimulation
Transcranial magnetic stimulation
DEVICESham Transcranial magnetic stimulation
Sham Transcranial magnetic stimulation
Sponsors
Tianjin University
Jilin University
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 80 Years
Healthy volunteers
No
Inclusion 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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Coma recovery scale-revised（CRS-R） | 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 |
| Change from the p300 in electroencephalogram | Assessment within 24 hours before, and 1 hour after TMS treatment | Assessment the p300 in event related potential(ERP) |
| Change from resting-state in electroencephalogram | Assessment within 24 hours before, and 1 hour after TMS treatment | Assessment the spectral power and coherence by in resting-state EEG |
| Change from TEP in electroencephalogram | Assessment within 24 hours before, and 1 hour after TMS treatment | Assessment the TMS Evoked Potential(TEP) |
| Change from PCI in electroencephalogram | Assessment within 24 hours before, and 1 hour after TMS treatment | Assessment the perturbational complexity index(PCI) in TMS-EEG |
| Change from ROI in neuroimage techniques-PET | 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. |
Countries
China
Outcome results
None listed