Study of Electro-acupuncture Treatment for Adults with Disorder of Consciousness After Brain Injury
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
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
Research Team
F
Fang Yuan, PhD
J
Jixiang Chen, PhD
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The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Lead Sponsor
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
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
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
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
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
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...