Vagus Nerve Stimulation for Physiological Responses

MH
Overseen ByMark Hartman, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Minnesota

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether transcutaneous auricular vagus nerve stimulation (taVNS) can affect physical and emotional responses in healthy college-aged individuals. The treatment uses a non-invasive device on the ear to stimulate the vagus nerve, potentially influencing how the body and mind react to various situations. The trial includes two groups: one receiving active stimulation (Active taVNS) and the other receiving a placebo (inactive treatment) for comparison. Ideal participants are college students who are generally healthy and do not have conditions like diabetes, heart rhythm issues, or epilepsy. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research in non-invasive treatments.

What prior data suggests that this method is safe for physiological responses?

Research has shown that transcutaneous auricular vagus nerve stimulation (taVNS) is generally safe for people. Studies indicate that taVNS is well-tolerated, with no serious side effects reported. Although some minor side effects have been noted, they are not considered significant. For example, a review of multiple studies confirmed the safety of taVNS and its potential for clinical use. Additionally, research found no harmful effects on the heart, such as a slow heart rate or irregular heart rhythm, supporting its safe development. Overall, taVNS appears to be a safe method to stimulate the vagus nerve without major risks.12345

Why are researchers excited about this trial?

Researchers are excited about the trial on Vagus Nerve Stimulation (taVNS) because it offers a new way to potentially improve physiological responses by directly stimulating the vagus nerve. Unlike traditional treatments that might focus on medication or lifestyle changes, taVNS uses a non-invasive approach to activate the body's natural pathways, which could lead to fewer side effects and more targeted outcomes. This method could pave the way for alternative therapies that harness the body's own mechanisms to enhance well-being.

What evidence suggests that this trial's treatments could be effective for physiological responses?

Research has shown that transcutaneous auricular vagus nerve stimulation (taVNS) may positively influence the body's responses. One study found that taVNS increased heart rate variability and certain skin responses, indicating changes in nervous system function. Another study demonstrated that taVNS improved movement abilities in participants. Additionally, taVNS has reduced the severity of insomnia, aiding sleep problems. It also affects brain areas related to balance and recovery, potentially benefiting various mental and physical health conditions. These findings suggest that taVNS can significantly impact the body's systems and overall health. Participants in this trial will receive either Active taVNS or Sham taVNS to further evaluate these effects.25678

Who Is on the Research Team?

MH

Mark Hartman, PhD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 18 and 35 years old.

Exclusion Criteria

I do not have epilepsy.
Participants will be excluded if they have clinically significant tachycardia or arrhythmia
Participants will be excluded if they have current pregnancy
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) to examine physiological and psychological responses

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Active taVNS
  • Sham taVNS

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: Active taVNSActive Control1 Intervention
Group II: Sham taVNSPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

Citations

Effects of taVNS on physiological responses and cognitive ...

Transcutaneous auricular vagus nerve stimulation increased heart rate variability and sympathetic electrodermal activity during the stimulation.

Effectiveness of transcutaneous auricular vagus nerve ...

The results showed that compared with the control group, the taVNS group demonstrated significantly increased motor function scores [standardized mean ...

Transcutaneous Auricular Vagus Nerve Stimulation for ...

In this randomized clinical trial, taVNS significantly reduced insomnia severity. Clinically meaningful enhancements in PSQI scores were observed compared with ...

The effects of non-invasive transcutaneous auricular vagus ...

Active taVNS induces activation of the fronto-vagal network, which has a therapeutic potential to generate salutogenic and balanced brain ...

Effects of transcutaneous auricular vagus nerve stimulation ...

Our results demonstrate the efficacy of a short-term application of non-invasive taVNS to modulate auditory processing in healthy individuals.

Safety of transcutaneous auricular vagus nerve stimulation ...

This is the first systematic review and meta-analysis of transcutaneous auricular stimulation safety. Overall, taVNS is a safe and feasible option for clinical ...

Transcutaneous auricular vagus nerve stimulation in ...

Although minor side effects were reported, no serious adverse events were attributed to taVNS parameters used. taVNS could regulate brain ...

The effects of transcutaneous auricular vagus nerve ...

This new, safe and effective way to stimulate the vagus nerve technique has been called Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) (Capone et al., ...