Electro-acupuncture to Treat Disorder of Consciousness

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥ 18 years;

With cerebral damage due to TBI;

Diagnosed with UWS or MCS based on at least two CRS-R assessments;

From 4 to 16 weeks from the onset of brain injury;

Disqualifiers

With a history of neurological or psychiatric disorder prior to the brain injury;

With uncontrolled seizures or status epilepticus;

Unstable vital signs and requiring the use of vasoactive agents;

With the use of general anesthetics or central acting sedative;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Electroacupuncture

    Other intervention

    Electro-acupuncture at Shuigou and Yintang.

  • Sham electroacupuncture

    Other intervention

    Sham-EA at sham-Shuigou and sham-Yintang.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Electro-acupuncture groupExperimental treatment 1 intervention
Group B: Sham electro-acupuncture groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Coma Recovery Scale - Revised score

0 - 23, a higher score indicates a better level of consciousness

Time frame
after 14 days of EA or sham-EA treatment

Secondary outcomes

1

phase locking value

measured by electroencephalogram

Time frame
after 14 days of EA or sham-EA treatment
2

amplitude of low-frequency fluctuation

measured by resting-state functional magnetic resonance imaging

Time frame
after 14 days of EA or sham-EA treatment
3

Amide proton transfer-weighted signal

measured by amide proton transfer imaging

Time frame
after 14 days of EA or sham-EA treatment
4

f value

measured by intravoxel incoherent motion imaging

Time frame
after 14 days of EA or sham-EA treatment

Other outcomes

Sponsors and contacts

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