Electro-acupuncture to Treat Disorder of Consciousness

Disorder of Consciousness Clinical Trial

Official title:

Electro-acupuncture to Treat Disorder of Consciousness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06268236
• Other study ID #: BF2023-252
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: January 31, 2026

Study information

• Verified date: February 2024
• Source: The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
• Contact: Fang Yuan, PhD
• Phone: +86-20-81887233
• Email: yuanfang[@]gzucm.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Consciousness Disorders
• Disorder of Consciousness
• Electroacupuncture

Intervention

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

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Guangzhou University of Chinese Medicine	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Front Neurosci. 2023 May 03;17:1208095. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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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. — View Citation

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. Erratum In: Cortex. 2023 May;162:136-139. — View Citation

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* Note: There are 15 references in all — Click here to view all references

Outcome

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