Disorder of Consciousness, Electroacupuncture
Conditions
Keywords
Acute brain injury, Disorder of consciousness, Electro-acupuncture, Awakening, Brain functional network
Brief summary
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.
Detailed description
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 .
Interventions
OTHERElectroacupuncture
Electro-acupuncture at Shuigou and Yintang.
OTHERSham electroacupuncture
Sham-EA at sham-Shuigou and sham-Yintang.
Sponsors
The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age ≥ 18 years; 2. With cerebral damage due to TBI； 3. Diagnosed with UWS or MCS based on at least two CRS-R assessments; 4. From 4 to 16 weeks from the onset of brain injury; 5. Informed consent obtained.
Exclusion criteria
1. With a history of neurological or psychiatric disorder prior to the brain injury; 2. With uncontrolled seizures or status epilepticus; 3. Unstable vital signs and requiring the use of vasoactive agents; 4. With the use of general anesthetics or central acting sedative; 5. Without intact skin at acupoints or sham points; 6. Concomitant medical illness that would interfere with the outcome assessments and/or follow-up 7. Pregnant patients; 8. Currently participating in other investigational trials; 9. High likelihood of not adhering to the study treatment or the follow-up regimen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coma Recovery Scale - Revised score | after 14 days of EA or sham-EA treatment | 0 - 23, a higher score indicates a better level of consciousness |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| phase locking value | after 14 days of EA or sham-EA treatment | measured by electroencephalogram |
| amplitude of low-frequency fluctuation | after 14 days of EA or sham-EA treatment | measured by resting-state functional magnetic resonance imaging |
| Amide proton transfer-weighted signal | after 14 days of EA or sham-EA treatment | measured by amide proton transfer imaging |
| f value | after 14 days of EA or sham-EA treatment | measured by intravoxel incoherent motion imaging |
| brain-computer interface accuracy | after 14 days of EA or sham-EA treatment | measured by electroencephalogram-based brain-computer interface experiment |
| latency value of N20 | after 14 days of EA or sham-EA treatment | measured by somatosensory evoked potential biomarkers |
| latency between III and V potentials | after 14 days of EA or sham-EA treatment | measured by brainstem auditory evoked potential |
| Glasgow Outcome Scale-Extended score | 30 days after randomization | 1 - 8, a higher score indicates better functional recovery from brain injury |
| neurite density index | after 14 days of EA or sham-EA treatment | measured by neurite orientation dispersion and density imaging |
Countries
China
Contacts
Primary ContactFang Yuan, PhD
Backup ContactJixiang Chen, PhD
Outcome results
None listed