Effect of taVNS on Patients With Disorders of Consciousness
NCT ID: NCT07284732
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-05-01
2027-05-31
Brief Summary
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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 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 transcutaneous auricular vagus nerve stimulation (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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Closed-Loop transcutaneous auricular vagus nerve stimulation
Stimulation will be delivered on the left cymba conchae using a silicone electrode
transcutaneous auricular vagus nerve stimulation
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.
Interventions
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transcutaneous auricular vagus nerve stimulation
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Zhujiang Hospital
OTHER
Responsible Party
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Qiuyou Xie
principal investigator
Locations
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Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Other Identifiers
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L20251010
Identifier Type: -
Identifier Source: org_study_id