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.
The AcuDoc trial is a single-center, prospective, triple masking, randomized, sham electroacupuncture-controlled study. A total of 50 adult patients with DOC and 25 healthy subjects will be enrolled in the study . Patients will be randomized into electroacupuncture (EA) group or sham EA group (1:1). All patients will receive EA or sham-EA treatment in the supine position at 9 am for 30 minutes once a day for consecutive 14 days and healthy subjects will receive no treatments. The primary objective is to determine the therapeutic benefit of electroacupuncture on the recovery of consciousness in patients with DOC after a 2-week intervention. Key secondary objective is to investigate the effect of electroacupuncture on the circuitry of consciousness using a multimodal approach integrating EEG, neuroimaging (rs-fMRI, amide proton transfer imaging, intravoxel incoherent motion imaging, neurite orientation dispersion and density imaging), and evoked potentials (SEP, BAEP). Other secondary outcomes include the effect of EA on the assessment of brain-computer interface after a 2-week intervention and on the Glasgow Outcome Scale-Extended score at 30 days and 90 days .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
Electro-acupuncture at Shuigou and Yintang.
Sham-EA at sham-Shuigou and sham-Yintang.
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China
RECRUITINGComa Recovery Scale - Revised score
0 - 23, a higher score indicates a better level of consciousness
Time frame: after 14 days of EA or sham-EA treatment
phase locking value
measured by electroencephalogram
Time frame: after 14 days of EA or sham-EA treatment
amplitude of low-frequency fluctuation
measured by resting-state functional magnetic resonance imaging
Time frame: after 14 days of EA or sham-EA treatment
Amide proton transfer-weighted signal
measured by amide proton transfer imaging
Time frame: after 14 days of EA or sham-EA treatment
f value
measured by intravoxel incoherent motion imaging
Time frame: after 14 days of EA or sham-EA treatment
neurite density index
measured by neurite orientation dispersion and density imaging
Time frame: after 14 days of EA or sham-EA treatment
latency value of N20
measured by somatosensory evoked potential biomarkers
Time frame: after 14 days of EA or sham-EA treatment
latency between III and V potentials
measured by brainstem auditory evoked potential
Time frame: after 14 days of EA or sham-EA treatment
Glasgow Outcome Scale-Extended score
1 - 8, a higher score indicates better functional recovery from brain injury
Time frame: 30 days after randomization
Glasgow Outcome Scale-Extended score
1 - 8, a higher score indicates better functional recovery from brain injury
Time frame: 90 days after randomization
brain-computer interface accuracy
measured by electroencephalogram-based brain-computer interface experiment
Time frame: after 14 days of EA or sham-EA treatment
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