Using electro-acupuncture to help patients with disorders of consciousness
Electro-acupuncture to Treat Disorder of Consciousness
This study is testing if electro-acupuncture can help improve awareness and brain function in adults with disorders of consciousness after brain injuries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06268236 on ClinicalTrials.gov |
What this trial studies
The AcuDoc trial aims to evaluate the effectiveness of electro-acupuncture in treating patients with disorders of consciousness (DOC) resulting from acute brain injuries. This single-center, randomized, sham-controlled study will enroll 50 adult patients diagnosed with DOC and 25 healthy subjects. Participants will receive either electro-acupuncture or sham treatment for 30 minutes daily over 14 days, with assessments conducted to measure recovery of consciousness and brain function using advanced neuroimaging and EEG techniques. The study seeks to provide insights into the therapeutic mechanisms of electro-acupuncture in this challenging clinical context.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with cerebral damage due to traumatic brain injury and diagnosed with unresponsive wakefulness syndrome or minimally conscious state.
Not a fit: Patients with a history of neurological or psychiatric disorders prior to their brain injury or those with unstable vital signs may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve recovery outcomes for patients with disorders of consciousness.
How similar studies have performed: While the use of electro-acupuncture in this context is novel, similar approaches in other studies have shown promising results in enhancing recovery in patients with brain injuries.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Guangzhou, Guangdong
- The Second Affiliated Hospital of Guangzhou University of Chinese Medicine — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Fang Yuan, PhD
- Email: yuanfang@gzucm.edu.cn
- Phone: +86-20-81887233
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.