Electro-acupuncture to Treat Disorder of Consciousness

NCT06268236 | Recruiting

• 1 other identifier: BF2023-252
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Disorder of Consciousness; Electroacupuncture

Keywords

Acute brain injury; Disorder of consciousness; Electro-acupuncture; Awakening; Brain functional network

Outcome Measures

Primary Outcomes (1)

• Coma Recovery Scale - Revised score

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

  after 14 days of EA or sham-EA treatment

Secondary Outcomes (10)

• phase locking value

  after 14 days of EA or sham-EA treatment

• amplitude of low-frequency fluctuation

  after 14 days of EA or sham-EA treatment

• Amide proton transfer-weighted signal

  after 14 days of EA or sham-EA treatment

• f value

  after 14 days of EA or sham-EA treatment

• neurite density index

  after 14 days of EA or sham-EA treatment

Study Arms (2)

Electro-acupuncture group

EXPERIMENTAL

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

Sham electro-acupuncture group

SHAM COMPARATOR

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

Interventions

Electroacupuncture OTHER

Electro-acupuncture at Shuigou and Yintang.

Electro-acupuncture group

Sham electroacupuncture OTHER

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

Sham electro-acupuncture group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine: lead

Study Sites (1)

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, 510120, China

RECRUITING

Related Publications (15)

• 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 BACKGROUND

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  PMID: 21040571 BACKGROUND

• 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.

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• 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.

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• 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.

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• 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 Congress of Rehabilitation Medicine; and the National Institute on Disability, Independent Living, and Rehabilitation Research. Neurology. 2018 Sep 4;91(10):461-470. doi: 10.1212/WNL.0000000000005928. Epub 2018 Aug 8.

  PMID: 30089617 BACKGROUND

• Li H, Zhang X, Sun X, Dong L, Lu H, Yue S, Zhang H. Functional networks in prolonged disorders of consciousness. Front Neurosci. 2023 Feb 17;17:1113695. doi: 10.3389/fnins.2023.1113695. eCollection 2023.

  PMID: 36875660 BACKGROUND

• Edlow BL, Claassen J, Schiff ND, Greer DM. Recovery from disorders of consciousness: mechanisms, prognosis and emerging therapies. Nat Rev Neurol. 2021 Mar;17(3):135-156. doi: 10.1038/s41582-020-00428-x. Epub 2020 Dec 14.

  PMID: 33318675 BACKGROUND

• Rudolph M, Pelletier JG, Pare D, Destexhe A. Characterization of synaptic conductances and integrative properties during electrically induced EEG-activated states in neocortical neurons in vivo. J Neurophysiol. 2005 Oct;94(4):2805-21. doi: 10.1152/jn.01313.2004. Epub 2005 Jul 13.

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• Howell K, Grill E, Klein AM, Straube A, Bender A. Rehabilitation outcome of anoxic-ischaemic encephalopathy survivors with prolonged disorders of consciousness. Resuscitation. 2013 Oct;84(10):1409-15. doi: 10.1016/j.resuscitation.2013.05.015. Epub 2013 Jun 6.

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• Perez P, Valente M, Hermann B, Sitt J, Faugeras F, Demeret S, Rohaut B, Naccache L. Auditory Event-Related "Global Effect" Predicts Recovery of Overt Consciousness. Front Neurol. 2021 Jan 8;11:588233. doi: 10.3389/fneur.2020.588233. eCollection 2020.

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• Threlkeld ZD, Bodien YG, Rosenthal ES, Giacino JT, Nieto-Castanon A, Wu O, Whitfield-Gabrieli S, Edlow BL. Functional networks reemerge during recovery of consciousness after acute severe traumatic brain injury. Cortex. 2018 Sep;106:299-308. doi: 10.1016/j.cortex.2018.05.004. Epub 2018 May 12.

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• Demertzi A, Tagliazucchi E, Dehaene S, Deco G, Barttfeld P, Raimondo F, Martial C, Fernandez-Espejo D, Rohaut B, Voss HU, Schiff ND, Owen AM, Laureys S, Naccache L, Sitt JD. Human consciousness is supported by dynamic complex patterns of brain signal coordination. Sci Adv. 2019 Feb 6;5(2):eaat7603. doi: 10.1126/sciadv.aat7603. eCollection 2019 Feb.

  PMID: 30775433 BACKGROUND

MeSH Terms

Conditions

Consciousness Disorders; Brain Injuries

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Fang Yuan, PhD

  The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

  STUDY DIRECTOR

Central Study Contacts

Fang Yuan, PhD

CONTACT

+86-20-81887233; yuanfang@gzucm.edu.cn

Jixiang Chen, PhD

CONTACT

756337176@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 20, 2024
• Study Start: January 1, 2024
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)