Electro-acupuncture to Treat Disorder of Consciousness
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 th
| Condition(s) | Disorder of Consciousness, Electroacupuncture |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 stud |
| Ages | 18 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine |
| Locations | Guangzhou, Guangdong, China |
| Start date | 2024-01-01 |
| NCT ID | NCT06268236 |
| Official listing | https://clinicaltrials.gov/study/NCT06268236 |