Effects of Transcutaneous Vagal Nerve Stimulation on Post-Surgical Return to Consciousness, Delirium, and Depression

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT07610655
Status
Recruiting
Apply to this trial

Conditions

  • Cognitive Impairment
  • Depression
  • Post Operative Delirium
  • Vagus Nerve Stimulation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Transcutaneous vagal nerve stimulation — DEVICE
    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.
  • Sham (No Treatment) — DEVICE
    The stimulator is flipped upside down so that the participant does not receive stimulation of the vagal nerve.

Study Details

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.

Key Dates

Start date
Apr 23, 2026
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
May 31, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: tcVNS Stimulation (Intervention)
    Transcutaneous vagal nerve stimulation (tcVNS)
  • Sham Comparator: Sham tcVNS stimulation (Control)
    Sham transcutaneous vagal nerve stimulation (Sham tcVNS)

Primary Outcome Measure

Aim 1: Primary Endpoint 1: Determine if administering auricular tcVNS enhances the speed of recovery of anesthesia. [ Time Frame: 24 Hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern University Feinberg School of MedicineChicagoIllinois60611
Jordan Wood, BS
[email protected]
312-695-0915
Bin Zhang, MS
[email protected]
312-695-7771
Charles Hogue, MD (PRINCIPAL_INVESTIGATOR)
Ravindra A Gupta, MD (SUB_INVESTIGATOR)
John Bebawy, MD (SUB_INVESTIGATOR)
Eyal Kimchi, MD, PhD (SUB_INVESTIGATOR)
Jacqueline Morano, MD (SUB_INVESTIGATOR)
Jamie Uejima, MD (SUB_INVESTIGATOR)
Kimberly Klafta, MD (SUB_INVESTIGATOR)

Find similar trials in Chicago, IL

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Northwestern University Feinberg School of Medicine· Chicago, IL

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