40 Participants NeededMy employer runs this trial

Vagal Nerve Stimulation for Post-Surgical Recovery

(tVNS Trial)

JW
Overseen ByJordan Wood, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Northwestern University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a non-invasive treatment called transcutaneous vagal nerve stimulation (tcVNS) can enhance recovery after surgery. Researchers aim to determine if this method can help patients wake up more smoothly from anesthesia, expedite discharge from the recovery room, and reduce post-surgery delirium and depression. The trial includes two groups: one receiving the actual tcVNS treatment and the other receiving a sham (fake) version for comparison. This trial may suit those undergoing lumbar surgery for back issues like degenerative disc disease or spinal stenosis. As an unphased trial, it offers patients the chance to contribute to innovative research that could improve surgical recovery.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that transcutaneous vagal nerve stimulation is safe for post-surgical recovery?

Research has shown that transcutaneous vagal nerve stimulation (tcVNS) is generally safe, with a low risk of serious side effects. Studies have found that tcVNS usually causes only mild and temporary issues, such as earaches, headaches, or a tingling sensation. These effects are not serious and do not last long. In past studies, no serious adverse events were reported. This suggests that tcVNS is well-tolerated and can be safely used in various situations, including recovery after surgery.12345

Why are researchers excited about this trial?

Transcutaneous vagal nerve stimulation (tcVNS) is unique because it uses a non-invasive method to potentially enhance post-surgical recovery by stimulating the vagus nerve through the skin. Unlike traditional treatments that might involve medication with various side effects, tcVNS offers a novel way to promote healing and reduce inflammation without drugs. Researchers are excited about this approach because it could provide a safer, more targeted way to speed up recovery times and improve overall patient outcomes after surgery.

What evidence suggests that transcutaneous vagal nerve stimulation is effective for post-surgical recovery?

Research has shown that transcutaneous vagal nerve stimulation (tcVNS) may enhance recovery after surgery. In this trial, participants will receive either tcVNS or a sham tcVNS as a control. Studies suggest that tcVNS can help manage pain, reduce swelling, and lower the risk of long-term pain post-surgery. Specifically, patients who received tcVNS reported better sleep and faster recovery of cognitive skills. Additionally, tcVNS seems to aid in more effective awakening after surgery compared to those who did not receive it. Overall, tcVNS appears to be a safe and effective method to improve surgical recovery.12367

Who Is on the Research Team?

CH

Charles Hogue, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for people who have just had surgery and are in the recovery room. It aims to see if a noninvasive nerve stimulation device can help with waking up, confusion (delirium), or depression after anesthesia.

Inclusion Criteria

Montreal Cognitive Assessment (MoCA) score ≥ 18 - accept mild
Ability to use a keyboard
Women of child-bearing age must be comfortable confirming a negative pregnancy prior to participating in the study
See 5 more

Exclusion Criteria

I have a narrowing in my carotid artery.
MoCA < 18
Other neurological diagnoses or a diagnosis of severe psychiatric disorder (e.g., psychosis) or a reported childhood learning disability
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive transcutaneous vagal nerve stimulation (tcVNS) or sham stimulation in the operating room and PACU

Immediate post-surgical period
In-person during surgery and PACU stay

Follow-up

Participants are monitored for cognitive recovery, delirium, and depression post-surgery

30 days
Assessments at baseline, post-operative days 1 and 2, and 30 days post-discharge

Long-term follow-up

Participants are assessed for long-term effects on cognitive function and quality of life

30 days post-discharge

What Are the Treatments Tested in This Trial?

Interventions

  • Transcutaneous Vagal Nerve Stimulation

Trial Overview

The study compares transcutaneous vagal nerve stimulation (a painless device placed on the skin) to a sham treatment (no real stimulation) to see if it helps patients recover faster and reduces delirium or depression after surgery.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: tcVNS Stimulation (Intervention)Active Control1 Intervention
Group II: Sham tcVNS stimulation (Control)Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

Citations

Transcutaneous auricular vagus nerve stimulation improves ...

No serious adverse events occurred. Conclusion: Perioperative taVNS safely improves postoperative recovery, partly through inhibiting IL-6/TNF-α, with ...

Transcutaneous Auricular Vagus Nerve Stimulation and ...

Existing evidence suggested that taVNS improves pain management, sleep quality, inflammatory responses, and gastrointestinal recovery after surgery. This study ...

Effectiveness of Transcutaneous Auricular Vagal Nerve... ...

taVNS did not reduce postoperative opioid consumption but alleviated acute postoperative pain, lowered the incidence of rebound pain and chronic postsurgical ...

Original Article Transcutaneous auricular vagus nerve ...

Abstract: Objective: This randomized controlled trial evaluated whether perioperative transcutaneous auricular va- gus nerve stimulation ...

Effects of Transcutaneous Vagal Nerve Stimulation on Post ...

This study will examine whether noninvasive, transcutaneous vagal nerve stimulation (tcVNS) can help restore consciousness in patients in ...

Safety of transcutaneous auricular vagus nerve stimulation ...

Although the general impression is that taVNS is a safe technique with only mild and transient adverse effects (AEs), human data on safety and ...

Transcutaneous Auricular Vagus Nerve Stimulation for ...

Conclusions and Relevance In this randomized clinical trial, taVNS significantly reduced uterine contraction pain, incisional pain, depression, and anxiety, and ...