Disorders of ConsciousnesstaVNSNCT07284732
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Patients With Disorders of Consciousness
A study testing transcutaneous auricular vagus nerve stimulation in people with Disorders of Consciousness, run by Zhujiang Hospital at 1 site in China.
Trial summary
Consciousness disorders following severe brain injury refer to a series of disturbances in arousal and cognition secondary to organic brain diseases, including Unresponsive Wakefulness Syndrome (UWS) (also termed Vegetative State, VS) and Minimally Conscious State (MCS). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Disorders of Consciousness
- What is being tested?
- transcutaneous auricular vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-70 years, with a disease duration exceeding 28 days but not longer than 1 year.
- Patients diagnosed with disorders of consciousness (DoC), specifically classified as either vegetative state (VS) or minimally conscious state (MCS) according to the Coma Recovery Scale-Revised (CRS-R) based on international guidelines.
- No prior history of neuropsychiatric disorders.
- Absence of contraindications to transcutaneous auricular vagus nerve stimulation (taVNS) or electroencephalography (EEG), and no concurrent use of sedatives or medications that may interfere with cerebral stimulation-including Na⁺ or Ca²⁺ channel blockers or NMDA receptor antagonists.
- Intact skin at the auricular site.
Who cannot join
- Participation in other trials involving non-invasive or invasive neuromodulation.
- Uncontrolled epilepsy, defined as seizures occurring within 4 weeks prior to enrollment.
- Presence of cranial metal implants, pacemakers, craniotomy at the stimulation site, implanted brain devices, or similar conditions.
- Cardiac arrhythmia or other significant cardiovascular abnormalities;
- History of respiratory disorders, including dyspnea, asthma, or hyperventilation.
- History of vasovagal syncope.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280
About this study
Official title: Effects of Pairing Transcutaneous Auricular Vagus Nerve Stimulation on Patients With Disorders of Consciousness: An Exploratory Single-Center Randomized Controlled Trial
Consciousness disorders following severe brain injury refer to a series of disturbances in arousal and cognition secondary to organic brain diseases, including Unresponsive Wakefulness Syndrome (UWS) (also termed Vegetative State, VS) and Minimally Conscious State (MCS). Disorders of consciousness(DoC) is listed in the International Statistical Classification of Diseases and Related Health Problems, though it is not currently recognized as an independent and consistent diagnostic category. According to epidemiological surveys, conservative estimates suggest that 70,000 to 100,000 new cases of DoC are reported annually in China, posing significant challenges for clinical diagnosis and treatment. Accurately assessing DoC, understanding its neurobiological underpinnings, and developing effective rehabilitation strategies remain subjects requiring further investigation through both clinical and basic neuroscience research.
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) is a non-invasive brain stimulation technique that delivers electrical impulses to the auricular branch of the vagus nerve. Substantial evidence indicates that taVNS serves as a therapeutic intervention for various neurological and psychiatric disorders, such as epilepsy, treatment-resistant depression, migraines, and cognitive impairments. As an emerging neurostimulation technique, taVNS has been investigated for its potential to promote the recovery of awareness in patients with DoC. However, clinical evidence remains limited, underscoring the need for further trials to substantiate its efficacy. Developed from traditional implanted Vagus Nerve Stimulation(VNS), taVNS offers high safety and minimal to negligible side effects, presenting a promising therapeutic avenue for patients with severe traumatic brain injury and disorders of consciousness.
Read more
Methods: This study is a single-arm trial. A total of 20 patients are planned to be enrolled. Each patient will receive taVNS twice daily over a period of 10 consecutive days, totaling 20 sessions. Primary and secondary outcome measures will be assessed at baseline and after the completion of taVNS treatment. The primary efficacy endpoint will be the change in behavioral responses as evaluated by the Coma Recovery Scale-Revised (CRS-R). Additionally, resting-state high-density electroencephalography (EEG) and combined transcranial magnetic stimulation with EEG (TMS-EEG) recordings will be utilized to investigate the neurophysiological correlates of taVNS intervention.
Discussion: This study will provide valuable insights to inform the selection of treatment approaches for patients with disorders of consciousness. By employing a pre-post within-subject comparison design, it aims to validate the therapeutic role of Closed-Loop Transcutaneous Auricular Vagus Nerve Stimulation (CL-taVNS) in this patient population.
- Conditions
- Disorders of Consciousness
- Being tested
- transcutaneous auricular vagus nerve stimulation
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous auricular vagus nerve stimulationDevice
The stimulation protocol consisted of pulse trains at a frequency of 100 Hz. A total of 400 paired RAVANS pulses were delivered per session. The intervention was administered twice daily for 10 consecutive days, resulting in a total of 20 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Closed-Loop transcutaneous auricular vagus nerve stimulation | Experimental | Stimulation will be delivered on the left cymba conchae using a silicone electrode Receives: Device: transcutaneous auricular vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline JKF Coma Recovery Scale-Revised(CRS-R)
The CRS-R comprises six subscales designed to assess auditory, visual, oromotor, communication,and arousal processes. Each CRS-R subscale score is determined based on the presence or absence of specific behavioral responses to sensory stimuli. The total score ranges from 0 to 23, with higher scores indicating a higher level of consciousness in patients with DoC.
Measured: immediately after 10 days TaVNS session
Secondary outcomes (2)
Change from Baseline Resting-State EEG
EEG data will be recorded for 10 minutes using a 66-channel cap arranged according to the International 10-20 System. From artifact-free EEG epochs, relative spectral power (RSP) and functional connectivity (FC) will be derived across five frequency bands: δ (1-4 Hz), θ (4-8 Hz), α (8-13 Hz), β (13-30 Hz), and γ (30-45 Hz). All analyses of RSP and FC will be performed offline.
Measured: immediately after 10 days TaVNS session
Change from Baseline TMS-EEG
Transcranial magnetic stimulation combined with electroencephalography (TMS-EEG) is an effective way to measure cortical activity.In this study, PCIst, a derivative version of PCI, PCIst was chosen as an alternative, which estimates the complexity of TMS perturbations by signal decomposition and recurrence quantification analysis (RQA).
Measured: immediately after 10 days TaVNS session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start1 May 2024
- Primary completion1 May 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorders of ConsciousnessStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiuyou Xie, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284732
- Sponsor's protocol ID
- L20251010
- Acronym
- taVNS
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pairing Transcutaneous Auricular Vagus Nerve Stimulation on Patients With Disorders of Consciousness: An Exploratory Single-Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07284732
- Acronym / sponsor ID
- taVNS / L20251010
- Conditions
- Disorders of Consciousness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 16 Dec 2025 (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.
Consciousness disorders following severe brain injury refer to a series of disturbances in arousal and cognition secondary to organic brain diseases, including Unresponsive Wakefulness Syndrome (UWS) (also termed Vegetative State, VS) and Minimally Conscious State (MCS). Disorders of consciousness(DoC) is listed in the International Statistical Classification of Diseases and Related Health Problems, though it is not currently recognized as an independent and consistent diagnostic category. According to epidemiological surveys, conservative estimates suggest that 70,000 to 100,000 new cases of DoC are reported annually in China, posing significant challenges for clinical diagnosis and treatment. Accurately assessing DoC, understanding its neurobiological underpinnings, and developing effective rehabilitation strategies remain subjects requiring further investigation through both clinical and basic neuroscience research.
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) is a non-invasive brain stimulation technique that delivers electrical impulses to the auricular branch of the vagus nerve. Substantial evidence indicates that taVNS serves as a therapeutic intervention for various neurological and psychiatric disorders, such as epilepsy, treatment-resistant depression, migraines, and cognitive impairments. As an emerging neurostimulation technique, taVNS has been investigated for its potential to promote the recovery of awareness in patients with DoC. However, clinical evidence remains limited, underscoring the need for further trials to substantiate its efficacy. Developed from traditional implanted Vagus Nerve Stimulation(VNS), taVNS offers high safety and minimal to negligible side effects, presenting a promising therapeutic avenue for patients with severe traumatic brain injury and disorders of consciousness.
Methods: This study is a single-arm trial. A total of 20 patients are planned to be enrolled. Each patient will receive taVNS twice daily over a period of 10 consecutive days, totaling 20 sessions. Primary and secondary outcome measures will be assessed at baseline and after the completion of taVNS treatment. The primary efficacy endpoint will be the change in behavioral responses as evaluated by the Coma Recovery Scale-Revised (CRS-R). Additionally, resting-state high-density electroencephalography (EEG) and combined transcranial magnetic stimulation with EEG (TMS-EEG) recordings will be utilized to investigate the neurophysiological correlates of taVNS intervention.
Discussion: This study will provide valuable insights to inform the selection of treatment approaches for patients with disorders of consciousness. By employing a pre-post within-subject comparison design, it aims to validate the therapeutic role of Closed-Loop Transcutaneous Auricular Vagus Nerve Stimulation (CL-taVNS) in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Closed-Loop transcutaneous auricular vagus nerve stimulation | Experimental | Device: transcutaneous auricular vagus nerve stimulationStimulation will be delivered on the left cymba conchae using a silicone electrode |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18-70 years, with a disease duration exceeding 28 days but not longer than 1 year.
- Patients diagnosed with disorders of consciousness (DoC), specifically classified as either vegetative state (VS) or minimally conscious state (MCS) according to the Coma Recovery Scale-Revised (CRS-R) based on international guidelines.
- No prior history of neuropsychiatric disorders.
- Absence of contraindications to transcutaneous auricular vagus nerve stimulation (taVNS) or electroencephalography (EEG), and no concurrent use of sedatives or medications that may interfere with cerebral stimulation-including Na⁺ or Ca²⁺ channel blockers or NMDA receptor antagonists.
- Intact skin at the auricular site.
Key exclusion criteria (6 listed)
- Participation in other trials involving non-invasive or invasive neuromodulation.
- Uncontrolled epilepsy, defined as seizures occurring within 4 weeks prior to enrollment.
- Presence of cranial metal implants, pacemakers, craniotomy at the stimulation site, implanted brain devices, or similar conditions.
- Cardiac arrhythmia or other significant cardiovascular abnormalities;
- History of respiratory disorders, including dyspnea, asthma, or hyperventilation.
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 |
|---|---|---|
| transcutaneous auricular vagus nerve stimulationThe stimulation protocol consisted of pulse trains at a frequency of 100 Hz. A total of 400 paired RAVANS pulses were delivered per session. The intervention was administered twice daily for 10 consecutive days, resulting in a total of 20 sessions. | Device | Closed-Loop transcutaneous auricular vagus nerve stimulation |
Primary outcome
Change from Baseline JKF Coma Recovery Scale-Revised(CRS-R)
Time frame: immediately after 10 days TaVNS session
The CRS-R comprises six subscales designed to assess auditory, visual, oromotor, communication,and arousal processes. Each CRS-R subscale score is determined based on the presence or absence of specific behavioral responses to sensory stimuli. The total score ranges from 0 to 23, with higher scores indicating a higher level of consciousness in patients with DoC.
2 secondary outcomes
Change from Baseline Resting-State EEG
Time frame: immediately after 10 days TaVNS session
Change from Baseline TMS-EEG
Time frame: immediately after 10 days TaVNS session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous auricular vagus nerve stimulation in people with Disorders of Consciousness, run by Zhujiang Hospital 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 6 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: looking for participants now, as of the sponsor's last update on 31 Mar 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact xiaoya Xiong (13392929402, xiongxiaoya0224@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline JKF Coma Recovery Scale-Revised(CRS-R) (time frame: immediately after 10 days TaVNS session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2026.