Effects of Transcutaneous Vagal Nerve Stimulation on Post-Surgical Return to Consciousness, Delirium, and Depression
NCT07610655 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-05-28
Summary
This study will examine whether noninvasive, transcutaneous vagal nerve stimulation (tcVNS) can help restore consciousness in patients in the operating room and the Post Anesthesia Care Unit (PACU). The study will also investigate if tcVNS can expedite discharge from the PACU and examine whether tcVNS administerd in the PACU helps reduce delirium and depression after surgery. The study will also evaluate whether tcVNS speeds cognitive recovery from emergence of anesthesia and surgery.
Conditions
- Post Operative Delirium
- Cognitive Impairment
- Vagus Nerve Stimulation
- Depression
Interventions
- DEVICE
-
Transcutaneous vagal nerve stimulation
The tcVNS device utilized in this study is not an implanted device, but rather is solely operated outside of the body by affixing it around the patient's ear. The device delivers stimulation of the vagus nerve at designated intensity, interval, and frequency.
- DEVICE
-
Sham (No Treatment)
The stimulator is flipped upside down so that the participant does not receive stimulation of the vagal nerve.
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Charles Hogue, MD · Northwestern University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-23
- Primary Completion
- 2028-12-31
- Completion
- 2029-05-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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