Electro-acupuncture to Treat Disorder of Consciousness

Guangzhou University of Chinese Medicine

Status: Enrolling

Conditions: Electroacupuncture; Disorder of Consciousness

Treatments: Other: Sham electroacupuncture; Other: Electroacupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06268236

BF2023-252

Details and patient eligibility

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.

Full 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 .

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Electro-acupuncture group

Experimental group

Description:

Patients in EA group receive acupuncture at Shuigou (also known as Renzhong, GV26) and Yintang (updated number GV24+, previous number GV29). Paired electrodes from the EA apparatus are clipped to the needle handles at Shuigou and Yintang. The electroacupuncture stimulation lasts for 30 minutes with a wave of rarefaction and condensation (10 Hz / 50 Hz) and a current intensity of the maximum withstand current within 7mA. All patients receive EA at 9 am for 30 minutes once a day for consecutive 14 days.

Treatment:

Other: Electroacupuncture

Sham electro-acupuncture group

Sham Comparator group

Description:

Patients in sham-EA group receive sham-EA at sham-Shuigou and sham-Yintang.Acupuncture needles are inserted into the adhesive pads but do not pierce the skin. Paired electrodes from the EA apparatus via sham connecting cords are clipped to the needle handles at sham-Shuigou and sham-Yintang. The sham connecting cords are similar in appearance to the normal ones, but the inner wires in sham connecting cords are cut off and cannot conduct electricity. All patients receive sham-EA at 9 am for 30 minutes once a day for consecutive 14 days.

Treatment:

Other: Sham electroacupuncture