NCT07610655 Effects of Transcutaneous Vagal Nerve Stimulation on Post-Surgical Return to Consciousness, Delirium, and Depression
| NCT ID | NCT07610655 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwestern University |
| Condition | Post Operative Delirium |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-04-23 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2026-04-23 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Aged \> 18 years of age 2. Patients undergoing lumbar surgery for degenerative disc disease or spinal stenosis involving two or more levels 3. Montreal Cognitive Assessment (MoCA) score ≥ 18 - accept mild 4. Ability to use a keyboard 5. Able to understand and communicate in English 6. Be able to consent independently 7. Women of child-bearing age must be comfortable confirming a negative pregnancy prior to participating in the study. 8. Must not be involved in any other research intervention study testing neurobehavioral functioning Exclusion Criteria: 1. Age \< 18 years of age 2. History of vagotomy (cutting the vagus nerve) 3. History of bradycardia, heart block, prolonged QT syndrome, brugada syndrome, heart failure with ejection fraction less than 35% and/or New York Heart Association symptoms 4. MoCA \< 18 5. History of seizure disorder or intracranial hemorrhage 6. Patients with carotid stenosis 7. Patients with aneurysms 8. Other neurological diagnoses or a diagnosis of severe psychiatric disorder (e.g., psychosis) or a reported childhood learning disability 9. Pregnancy, breastfeeding 10. Active addiction history 11. ECG adhesive allergy 12. Severe aphasia, preventing subject from understanding the protocol and giving written consent 13. Patients will be excluded postoperatively if there is neck swelling at the proposed site of left tcVNS.
Contact & Investigator
Charles Hogue, MD
PRINCIPAL INVESTIGATOR
Northwestern University
Frequently Asked Questions
Who can join the NCT07610655 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Post Operative Delirium. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07610655 currently recruiting?
Yes, NCT07610655 is actively recruiting participants. Contact the research team at jordan.wood1@northwestern.edu for enrollment information.
Where is the NCT07610655 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT07610655 clinical trial?
NCT07610655 is sponsored by Northwestern University. The principal investigator is Charles Hogue, MD at Northwestern University. The trial plans to enroll 40 participants.