The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Phase
Not applicable
Started
2024-01-01
Last updated
2024-09-19
Condition(s) studied
Disorder of ConsciousnessElectroacupuncture
Investigational drug(s) / intervention(s)
ElectroacupunctureSham electroacupuncture
Electroacupuncture: Electro-acupuncture at Shuigou and Yintang.
Sham electroacupuncture: Sham-EA at sham-Shuigou and sham-Yintang.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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
Primary outcome measure(s)
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
Trial sites (1)
Facility
City
Region
Status
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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