Transauricular vagus nerve stimulation for hospital delirium
Transauricular Vagus Nerve Stimulation (taVNS) for Delirium
This trial will test whether a non-invasive ear-based vagus nerve stimulation device (taVNS) is safe, tolerable, and may help adults in the hospital who develop delirium.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Stony Brook University Academic / other |
| Locations | 1 site (Stony Brook, New York) |
| Trial ID | NCT07258082 on ClinicalTrials.gov |
What this trial studies
This is a single-arm, open-label feasibility study enrolling up to 10 hospitalized adults with delirium at Stony Brook University Hospital. All participants will receive transauricular vagus nerve stimulation in addition to usual care, with treatments begun within 24 hours of enrollment and monitored for safety and tolerability. Investigators will record EEG and brain oxygen saturation (rSO2) to look for physiological changes and will use the ICDSC to document delirium severity. The study uses legally authorized representatives for consent when patients lack capacity and has no randomization or placebo group.
Who should consider this trial
Good fit: Ideal candidates are right-handed adult inpatients over age 22 at Stony Brook who screen positive for delirium on the ICDSC, are not intubated, and have no implanted stimulators, pacemakers, epilepsy, recent substance abuse, pregnancy, or other contraindications.
Not a fit: Patients with severe permanent neurologic disability, implanted VNS or pacemakers, a history of epilepsy, recent substance abuse, pregnancy, weight under 40 kg, or who are intubated are excluded and would not receive benefit from participation.
Why it matters
Potential benefit: If successful, taVNS could offer a low-risk, bedside treatment that reduces delirium severity or shortens recovery time for hospitalized patients.
How similar studies have performed: taVNS has shown promising physiological and symptomatic effects in small pilot studies for other neurological and psychiatric conditions, but its use specifically for delirium in critically ill inpatients is novel and largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Stony Brook University Hospital inpatient, Age \> 22 * Right- handed * Screen positive for delirium on ICDSC instrument Exclusion Criteria: * Severe neurologic disability including severe traumatic brain injury, severe permanent cognitive impairment * Pacemaker present * Implanted VNS stimulator present * Personal history of epilepsy * Facial or ear pain or trauma * Recent history of substance abuse * Any other medical condition that, in the judgment of the investigator, makes participation in the study unsafe. * Weight \< 40kg * Pregnant females * Intubated patient
Where this trial is running
Stony Brook, New York
- Stony Brook University Hospital — Stony Brook, New York, United States (Recruiting)
Study contacts
- Principal investigator: Isadora Botwinick, MD — Stony Brook University Hospital
- Study coordinator: Isadora Botwinick, MD
- Email: isadora.botwinick@stonybrookmedicine.edu
- Phone: 631-444-8329
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.