Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06268236

Electro-acupuncture to Treat Disorder of Consciousness

Led by The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine · Updated on 2024-09-19

50

Participants Needed

1

Research Sites

108 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Electro-acupuncture to Treat Disorder of Consciousness

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 18 years
  • Cerebral damage due to traumatic brain injury
  • Diagnosed with unresponsive wakefulness syndrome (UWS) or minimally conscious state (MCS) based on at least two Coma Recovery Scale-Revised assessments
  • Between 4 and 16 weeks from the onset of brain injury
  • Informed consent obtained
Not Eligible

You will not qualify if you...

  • History of neurological or psychiatric disorder prior to the brain injury
  • Uncontrolled seizures or status epilepticus
  • Unstable vital signs requiring vasoactive agents
  • Use of general anesthetics or central acting sedatives
  • Lack of intact skin at acupoints or sham points
  • Medical illness interfering with outcome assessments or follow-up
  • Pregnant patients
  • Currently participating in other investigational trials
  • High likelihood of not adhering to study treatment or follow-up regimen

AI-Screening

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Trial Site Locations

Total: 1 location

1

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China, 510120

Actively Recruiting

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Research Team

F

Fang Yuan, PhD

CONTACT

J

Jixiang Chen, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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