Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-24 @ 9:59 PM
NCT ID:
NCT07284732
Eligibility Criteria:
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07284732
Study Brief:
Protocol Section:
NCT07284732