Disorder of ConsciousnessNCT06268236
Electro-acupuncture to Treat Disorder of Consciousness
A study testing Electroacupuncture in people with Disorder of Consciousness and Electroacupuncture, run by The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Disorder of Consciousness, Electroacupuncture
- What is being tested?
- Electroacupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Pregnant patients;
- Currently participating in other investigational trials;
- High likelihood of not adhering to the study treatment or the follow-up regimen
Trial locations and contacts
1 site in 1 country.
Jixiang Chen, PhD contact
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, 510120
Fang Yuan, PhD, +86-20-81887233, plawlx@gzucm.edu.cn
About this study
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.
Read the 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 .
- Conditions
- Disorder of Consciousness, Electroacupuncture
- Being tested
- Electroacupuncture, Sham electroacupuncture
- Keywords
- Acute brain injury, Disorder of consciousness, Electro-acupuncture, Awakening, Brain functional network
- Medical subject headings
- Consciousness Disorders, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureOther
Electro-acupuncture at Shuigou and Yintang.
Sham electroacupunctureOther
Sham-EA at sham-Shuigou and sham-Yintang.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sham electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coma Recovery Scale - Revised score
0 - 23, a higher score indicates a better level of consciousness
Measured: after 14 days of EA or sham-EA treatment
Secondary outcomes (10)
phase locking value
measured by electroencephalogram
Measured: after 14 days of EA or sham-EA treatment
amplitude of low-frequency fluctuation
measured by resting-state functional magnetic resonance imaging
Measured: after 14 days of EA or sham-EA treatment
Amide proton transfer-weighted signal
measured by amide proton transfer imaging
Measured: after 14 days of EA or sham-EA treatment
f value
measured by intravoxel incoherent motion imaging
Measured: after 14 days of EA or sham-EA treatment
neurite density index
measured by neurite orientation dispersion and density imaging
Measured: after 14 days of EA or sham-EA treatment
latency value of N20
measured by somatosensory evoked potential biomarkers
Measured: after 14 days of EA or sham-EA treatment
latency between III and V potentials
measured by brainstem auditory evoked potential
Measured: after 14 days of EA or sham-EA treatment
Glasgow Outcome Scale-Extended score
1 - 8, a higher score indicates better functional recovery from brain injury
Measured: 30 days after randomization
Glasgow Outcome Scale-Extended score
1 - 8, a higher score indicates better functional recovery from brain injury
Measured: 90 days after randomization
brain-computer interface accuracy
measured by electroencephalogram-based brain-computer interface experiment
Measured: after 14 days of EA or sham-EA treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Jan 2024
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Disorder of ConsciousnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Yuan, The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
- Investigators
- Fang Yuan, PhD, Study director, The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268236
- Sponsor's protocol ID
- BF2023-252
- Status last verified
- Sep 2024
- First submitted
- 2 Feb 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The detailed datasets used and/or analyzed during the current study are available upon reasonable request.
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.
PubMed 31003899Laureys 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.
PubMed 21040571Giacino 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.
PubMed 11839831Bruno 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.
PubMed 21674197Steriade 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.
PubMed 8340806Timofeev 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.
PubMed 11073868Schiff 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.
PubMed 19954851Giacino 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.
PubMed 30089617Li 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.
PubMed 36875660Edlow 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.
PubMed 33318675Rudolph 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.
PubMed 16014785Howell 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.
PubMed 23747956Perez 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.
PubMed 33488494Threlkeld 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.
PubMed 29871771Demertzi 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.
PubMed 30775433
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electro-acupuncture to Treat Disorder of Consciousness
- ClinicalTrials.gov ID
- NCT06268236
- Acronym / sponsor ID
- BF2023-252
- Conditions
- Disorder of Consciousness, Electroacupuncture
- Keywords
- Acute brain injury, Disorder of consciousness, Electro-acupuncture, Awakening, Brain functional network
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital, Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electro-acupuncture group | Experimental | Other: ElectroacupuncturePatients 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. |
| Sham electro-acupuncture group | Sham comparator | Other: Sham electroacupuncturePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroacupunctureElectro-acupuncture at Shuigou and Yintang. | Other | Electro-acupuncture group |
| Sham electroacupunctureSham-EA at sham-Shuigou and sham-Yintang. | Other | Sham electro-acupuncture group |
Primary outcome
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
10 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 31003899Thibaut 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.
- Background: PubMed 21040571Laureys 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.
- Background: PubMed 11839831Giacino 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.
- Background: PubMed 21674197Bruno 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.
- Background: PubMed 8340806Steriade 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.
- Background: PubMed 11073868Timofeev 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.
- Background: PubMed 19954851Schiff 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.
- Background: PubMed 30089617Giacino 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.
- Background: PubMed 36875660Li 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.
- Background: PubMed 33318675Edlow 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.
- Background: PubMed 16014785Rudolph 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.
- Background: PubMed 23747956Howell 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.
- Individual participant dataSharing planned: No. The detailed datasets used and/or analyzed during the current study are available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jixiang Chen, PhD contact
Fang Yuan, PhD study director
The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture in people with Disorder of Consciousness and Electroacupuncture, run by The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fang Yuan, PhD (+86-20-81887233, yuanfang@gzucm.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coma Recovery Scale - Revised score (time frame: after 14 days of EA or sham-EA treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06268236, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.