Clinical trial NCT06268236: Electro-acupuncture to Treat Disorder of Consciousness
Official title: Electro-acupuncture to Treat Disorder of Consciousness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Disorder of Consciousness
Electroacupuncture
Keywords: Acute brain injury
Disorder of consciousness
Electro-acupuncture
Awakening
Brain functional network
Lead sponsor: The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The AcuDoc trial is a single-center, prospective, triple masking, randomized, sham electroacupuncture-controlled study. A total of 50 adult patients with DOC and 25 healthy subjects will be enrolled in the study . Patients will be randomized into electroacupuncture (EA) group or sham EA group (1:1). All patients will receive EA or sham-EA treatment in the supine position at 9 am for 30 minutes once a day for consecutive 14 days and healthy subjects will receive no treatments. The primary objective is to determine the therapeutic benefit of electroacupuncture on the recovery of consciousness in patients with DOC after a 2-week intervention. Key secondary objective is to investigate the effect of electroacupuncture on the circuitry of consciousness using a multimodal approach integrating EEG, neuroimaging (rs-fMRI, amide proton transfer imaging, intravoxel incoherent motion imaging, neurite orientation dispersion and density imaging), and evoked potentials (SEP, BAEP). Other secondary outcomes include the effect of EA on the assessment of brain-computer interface after a 2-week intervention and on the Glasgow Outcome Scale-Extended score at 30 days and 90 days .

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

Primary outcomes:
measure: Coma Recovery Scale - Revised score
timeFrame: after 14 days of EA or sham-EA treatment
Secondary outcomes:
measure: phase locking value
timeFrame: after 14 days of EA or sham-EA treatment
measure: amplitude of low-frequency fluctuation
timeFrame: after 14 days of EA or sham-EA treatment
measure: Amide proton transfer-weighted signal
timeFrame: after 14 days of EA or sham-EA treatment
measure: f value
timeFrame: after 14 days of EA or sham-EA treatment
measure: neurite density index
timeFrame: after 14 days of EA or sham-EA treatment
measure: latency value of N20
timeFrame: after 14 days of EA or sham-EA treatment
measure: latency between III and V potentials
timeFrame: after 14 days of EA or sham-EA treatment
measure: Glasgow Outcome Scale-Extended score
timeFrame: 30 days after randomization
measure: Glasgow Outcome Scale-Extended score
timeFrame: 90 days after randomization
measure: brain-computer interface accuracy
timeFrame: after 14 days of EA or sham-EA treatment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
state: Guangdong
Study officials:
affiliation: The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
name: Fang Yuan, PhD
role: STUDY_DIRECTOR
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