Menu
Recruiting NCT06268236

Electro-acupuncture to Treat Disorder of Consciousness

No phase Interventional Disorder of Consciousness Electroacupuncture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electroacupuncture, Sham electroacupuncture.
Who it may be relevant to
Registry conditions: Disorder of Consciousness, Electroacupuncture. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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 .

Interventions

  • Other Electroacupuncture
    Electro-acupuncture at Shuigou and Yintang.
  • Other Sham electroacupuncture
    Sham-EA at sham-Shuigou and sham-Yintang.

Primary outcome measures

  • Coma Recovery Scale - Revised score [Time frame: after 14 days of EA or sham-EA treatment]
Secondary outcome measures (10)
  • phase locking value [Time frame: 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]
  • Amide proton transfer-weighted signal [Time frame: after 14 days of EA or sham-EA treatment]
  • f value [Time frame: after 14 days of EA or sham-EA treatment]
  • neurite density index [Time frame: after 14 days of EA or sham-EA treatment]
  • latency value of N20 [Time frame: 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]
  • Glasgow Outcome Scale-Extended score [Time frame: 30 days after randomization]
  • Glasgow Outcome Scale-Extended score [Time frame: 90 days after randomization]
  • brain-computer interface accuracy [Time frame: after 14 days of EA or sham-EA treatment]

Eligibility criteria

Inclusion criteria

  • 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;
  • Informed consent obtained.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The Second Affiliated Hospital of Guangzhou University of Chinese Medicine — Guangzhou

Publications

  • Thibaut A, Schiff N, Giacino J, Laureys S, Gosseries O. Therapeutic interventions in patients with prolonged disorders of consciousness. Lancet Neurol. 2019 Jun;18(6):600-614. doi: 10.1016/S1474-4422(19)30031-6. Epub 2019 Apr 16. PMID 31003899
  • Laureys S, Celesia GG, Cohadon F, Lavrijsen J, Leon-Carrion J, Sannita WG, Sazbon L, Schmutzhard E, von Wild KR, Zeman A, Dolce G; European Task Force on Disorders of Consciousness. Unresponsive wakefulness syndrome: a new name for the vegetative state or apallic syndrome. BMC Med. 2010 Nov 1;8:68. doi: 10.1186/1741-7015-8-68. PMID 21040571
  • Giacino JT, Ashwal S, Childs N, Cranford R, Jennett B, Katz DI, Kelly JP, Rosenberg JH, Whyte J, Zafonte RD, Zasler ND. The minimally conscious state: definition and diagnostic criteria. Neurology. 2002 Feb 12;58(3):349-53. doi: 10.1212/wnl.58.3.349. PMID 11839831
  • Bruno MA, Vanhaudenhuyse A, Thibaut A, Moonen G, Laureys S. From unresponsive wakefulness to minimally conscious PLUS and functional locked-in syndromes: recent advances in our understanding of disorders of consciousness. J Neurol. 2011 Jul;258(7):1373-84. doi: 10.1007/s00415-011-6114-x. Epub 2011 Jun 16. PMID 21674197
  • Steriade M, Nunez A, Amzica F. A novel slow (< 1 Hz) oscillation of neocortical neurons in vivo: depolarizing and hyperpolarizing components. J Neurosci. 1993 Aug;13(8):3252-65. doi: 10.1523/JNEUROSCI.13-08-03252.1993. PMID 8340806
  • Timofeev I, Grenier F, Bazhenov M, Sejnowski TJ, Steriade M. Origin of slow cortical oscillations in deafferented cortical slabs. Cereb Cortex. 2000 Dec;10(12):1185-99. doi: 10.1093/cercor/10.12.1185. PMID 11073868
  • Schiff ND. Recovery of consciousness after brain injury: a mesocircuit hypothesis. Trends Neurosci. 2010 Jan;33(1):1-9. doi: 10.1016/j.tins.2009.11.002. Epub 2009 Dec 1. PMID 19954851
  • Giacino JT, Katz DI, Schiff ND, Whyte J, Ashman EJ, Ashwal S, Barbano R, Hammond FM, Laureys S, Ling GSF, Nakase-Richardson R, Seel RT, Yablon S, Getchius TSD, Gronseth GS, Armstrong MJ. 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 Co PMID 30089617

Identifiers

NCT: NCT06268236 · BF2023-252

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗