Electro-acupuncture to Treat Disorder of Consciousness

Launched by THE SECOND AFFILIATED HOSPITAL, GUANGZHOU UNIVERSITY OF TRADITIONAL CHINESE MEDICINE · Feb 12, 2024

Keywords

ClinConnect Summary

This clinical trial, called the AcuDoc trial, is exploring the use of electro-acupuncture as a potential treatment for people with disorders of consciousness (DOC), which can happen after a severe brain injury. Many individuals survive these injuries but may remain in states like unresponsive wakefulness or minimally conscious states. The trial aims to see if electro-acupuncture can help improve their condition and to understand how it works by using various tests that measure brain activity and behavior.

To participate in this trial, individuals must be at least 18 years old, have suffered a brain injury resulting in DOC, and have been assessed to be in a specific state of consciousness for 4 to 16 weeks. The trial is currently recruiting participants, and it is important that those interested do not have prior neurological disorders, uncontrolled seizures, or other serious health issues. If eligible, participants can expect to receive electro-acupuncture treatment and undergo several assessments throughout the study to monitor their progress and response to the treatment.

Gender

ALL

Eligibility 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