Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06268236

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

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the use of electroacupuncture as a treatment for adults with prolonged disorders of consciousness (DOC) caused by severe brain injury, such as traumatic brain injury (TBI). This trial aims to confirm whether electroacupuncture can help patients recover consciousness and to understand how it may affect brain function through advanced tests like EEG, neuroimaging, evoked potentials, and behavioral assessments. The study is a randomized, triple-masked trial that will enroll 50 adult patients with DOC and 25 healthy volunteers. Patients will be assigned to either receive real electroacupuncture or a sham version, both administered once daily at 9 am for 30 minutes over two weeks. Treatment involves acupuncture needles placed at specific points on the head with electrical stimulation in the real group, while the sham group receives a similar procedure without skin penetration or electrical current. Participants will undergo various assessments including consciousness scales, brain imaging, and brain-computer interface tests before and after the 14-day treatment period. Additional outcome measures will be recorded at 30 and 90 days to evaluate longer-term effects. Healthy subjects will not receive treatment but serve as controls for brain function tests. Researchers will monitor safety and treatment adherence throughout the study, which is expected to conclude by January 2026.

CONDITIONS

Brief 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 18 years or older
  • 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 brain injury onset
  • Informed consent obtained
Not Eligible

You will not qualify if you...

  • History of neurological or psychiatric disorder before brain injury
  • Uncontrolled seizures or status epilepticus
  • Unstable vital signs requiring vasoactive agents
  • Use of general anesthetics or central acting sedatives
  • Skin not intact at acupuncture or sham points
  • Medical illness interfering with assessments or follow-up
  • Pregnancy
  • Participation in other investigational trials
  • Likely to not adhere to treatment or follow-up requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 14 consecutive days

Participants receive daily electro-acupuncture or sham electro-acupuncture treatment for 30 minutes each morning in a supine position.

14 daily visits (in-person)

Follow-up

Duration - Up to 90 days after randomization

Participants are assessed for recovery and brain function outcomes after treatment, including assessments at 30 and 90 days post-randomization.

2 follow-up visits (in-person) at 30 and 90 days

Trial Site Locations

Total: 1 location

1

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China, 510120

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Research Team

F

Fang Yuan, PhD

J

Jixiang Chen, PhD

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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Published Research Related To This Trial

From unresponsive wakefulness to minimally conscious PLUS and functional locked-in syndromes: recent advances in our understanding of disorders of consciousness.

Marie-Aurélie Bruno, Audrey Vanhaudenhuyse, Aurore Thibaut...

https://pubmed.ncbi.nlm.nih.gov/21674197

Comprehensive systematic review update summary: Disorders of consciousness: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology; the American Congress of Rehabilitation Medicine; and the National Institute on Disability, Independent Living, and Rehabilitation Research.

Joseph T Giacino, Douglas I Katz, Nicholas D Schiff...

https://pubmed.ncbi.nlm.nih.gov/30089617