About this trial
With the rapid development of life support technology, more and more people can survive severe brain injury. Some survivors regain consciousness after a period of coma, however, many patients develop prolonged disorders of consciousness (DOC), which poses a therapeutic challenge for clinicians and a heavy burden for their families. The investigators design an Electro-acupuncture to treat disorder of consciousness (AcuDoc) trial with the aim of validating the clinical effect of electroacupuncture in treating DOC and exploring its therapeutic mechanisms by integrating EEG, neuroimaging, evoked potential tests, and behavioral assessments.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥ 18 years;
With cerebral damage due to TBI;
Diagnosed with UWS or MCS based on at least two CRS-R assessments;
From 4 to 16 weeks from the onset of brain injury;
Disqualifiers
With a history of neurological or psychiatric disorder prior to the brain injury;
With uncontrolled seizures or status epilepticus;
Unstable vital signs and requiring the use of vasoactive agents;
With the use of general anesthetics or central acting sedative;
Trial design
Parallel
Treatments tested in this trial
Electroacupuncture
Other interventionElectro-acupuncture at Shuigou and Yintang.
Sham electroacupuncture
Other interventionSham-EA at sham-Shuigou and sham-Yintang.
Treatment groups
Trial outcomes
Primary outcomes
Coma Recovery Scale - Revised score
0 - 23, a higher score indicates a better level of consciousness
Secondary outcomes
phase locking value
measured by electroencephalogram
amplitude of low-frequency fluctuation
measured by resting-state functional magnetic resonance imaging
Amide proton transfer-weighted signal
measured by amide proton transfer imaging
f value
measured by intravoxel incoherent motion imaging
Sponsors and contacts
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