Electro-acupuncture to Treat Disorder of Consciousness

Обзор

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.

Подробное описание

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 .

Вмешательства

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

Первичные конечные точки

• Coma Recovery Scale - Revised score [Срок оценки: after 14 days of EA or sham-EA treatment]

Вторичные конечные точки (10)

• phase locking value [Срок оценки: after 14 days of EA or sham-EA treatment]
• amplitude of low-frequency fluctuation [Срок оценки: after 14 days of EA or sham-EA treatment]
• Amide proton transfer-weighted signal [Срок оценки: after 14 days of EA or sham-EA treatment]
• f value [Срок оценки: after 14 days of EA or sham-EA treatment]
• neurite density index [Срок оценки: after 14 days of EA or sham-EA treatment]
• latency value of N20 [Срок оценки: after 14 days of EA or sham-EA treatment]
• latency between III and V potentials [Срок оценки: after 14 days of EA or sham-EA treatment]
• Glasgow Outcome Scale-Extended score [Срок оценки: 30 days after randomization]
• Glasgow Outcome Scale-Extended score [Срок оценки: 90 days after randomization]
• brain-computer interface accuracy [Срок оценки: after 14 days of EA or sham-EA treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Second Affiliated Hospital of Guangzhou University of Chinese Medicine — Гуанчжоу

Публикации

• 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

Идентификаторы

NCT: NCT06268236 · BF2023-252

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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