Electro-acupuncture to Treat Disorder of Consciousness

February 12, 2024 updated by: Fang Yuan, The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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. With contraindications to the MRI;
  6. Without intact skin at acupoints or sham points;
  7. Concomitant medical illness that would interfere with the outcome assessments and/or follow-up
  8. Pregnant patients;
  9. Currently participating in other investigational trials;
  10. High likelihood of not adhering to the study treatment or the follow-up regimen

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electro-acupuncture group
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.
Other: Electroacupuncture
Electro-acupuncture at Shuigou and Yintang.
Sham Comparator: Sham electro-acupuncture group
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.
Other: Sham electroacupuncture
Sham-EA at sham-Shuigou and sham-Yintang.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coma Recovery Scale - Revised score
Time Frame: after 14 days of EA or sham-EA treatment
0 - 23, a higher score indicates a better level of consciousness
after 14 days of EA or sham-EA treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
phase locking value
Time Frame: after 14 days of EA or sham-EA treatment
measured by electroencephalogram
after 14 days of EA or sham-EA treatment
amplitude of low-frequency fluctuation
Time Frame: after 14 days of EA or sham-EA treatment
measured by resting-state functional magnetic resonance imaging
after 14 days of EA or sham-EA treatment
Amide proton transfer-weighted signal
Time Frame: after 14 days of EA or sham-EA treatment
measured by amide proton transfer imaging
after 14 days of EA or sham-EA treatment
f value
Time Frame: after 14 days of EA or sham-EA treatment
measured by intravoxel incoherent motion imaging
after 14 days of EA or sham-EA treatment
neurite density index
Time Frame: after 14 days of EA or sham-EA treatment
measured by neurite orientation dispersion and density imaging
after 14 days of EA or sham-EA treatment
latency value of N20
Time Frame: after 14 days of EA or sham-EA treatment
measured by somatosensory evoked potential biomarkers
after 14 days of EA or sham-EA treatment
latency between III and V potentials
Time Frame: after 14 days of EA or sham-EA treatment
measured by brainstem auditory evoked potential
after 14 days of EA or sham-EA treatment
Glasgow Outcome Scale-Extended score
Time Frame: 30 days after randomization
1 - 8, a higher score indicates better functional recovery from brain injury
30 days after randomization
Glasgow Outcome Scale-Extended score
Time Frame: 90 days after randomization
1 - 8, a higher score indicates better functional recovery from brain injury
90 days after randomization
brain-computer interface accuracy
Time Frame: after 14 days of EA or sham-EA treatment
measured by electroencephalogram-based brain-computer interface experiment
after 14 days of EA or sham-EA treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Investigators

  • Study Director: Fang Yuan, PhD, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

February 2, 2024

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BF2023-252

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The detailed datasets used and/or analyzed during the current study are available upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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