30 Participants NeededMy employer runs this trial

Vagus Nerve Stimulation for Reaction Time

WG
Overseen ByWeiqing Ge Ge, DPT, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Youngstown State 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 how stimulating the vagus nerve with a small device on the ear can affect reaction times. The goal is to determine if this non-invasive technique helps people respond faster in certain situations. The procedure is simple and painless, using a TENS unit commonly found in physical therapy. The trial seeks healthy adults who have not tried vagus nerve stimulation and do not have metal in their skull or implanted devices.

As an unphased trial, participants contribute to innovative research that could lead to new non-invasive therapies.

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.

What prior data suggests that this device is safe for vagus nerve stimulation?

Research has shown that transcutaneous vagus nerve stimulation (tVNS) is generally safe and well-tolerated. In one study, mild skin irritation was the most common side effect, occurring in about 18% of participants.

Overall, tVNS maintains a good safety record. Another source notes that side effects are usually mild and temporary. This makes tVNS an appealing option for those seeking a non-surgical treatment.12345

Why are researchers excited about this trial?

Vagus nerve stimulation is unique because it uses a non-invasive technique to potentially improve reaction time. Unlike traditional treatments that might involve medication or invasive procedures, this approach uses a TENS unit to stimulate the vagus nerve through the skin on the ear, offering a pain-free experience. Researchers are excited about this method because it provides a new way to target the nervous system directly, possibly leading to quicker and more effective improvements in reaction time without the side effects associated with drugs.

What evidence suggests that vagus nerve stimulation is effective for improving reaction time?

Studies have shown that stimulating the vagus nerve without surgery can help people react faster. One study found that participants who received this treatment had quicker reaction times compared to those who received a placebo. In this trial, participants will receive non-invasive vagus nerve stimulation using a device similar to a TENS unit to gently stimulate the vagus nerve near the ear, potentially boosting brain function. This method has been safely used in other health conditions and has shown promising results in enhancing certain brain activities. The goal is to activate the vagus nerve to help people respond more quickly in tasks requiring fast reactions.12567

Are You a Good Fit for This Trial?

This trial is for healthy adults over 18 who have never had vagus nerve stimulation before.

Inclusion Criteria

I am healthy and over 18 years old.
* did not receive vagus nerve stimulation previously

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Non-Invasive Vagus Nerve Stimulation using a TENS unit for 5 minutes

1 day
1 visit (in-person)

Follow-up

Participants are monitored for reaction time immediately after the intervention

Immediate

What Are the Treatments Tested in This Trial?

Interventions

  • Vagus Nerve Stimulation

Trial Overview

Researchers are testing if non-invasive electrical stimulation of the vagus nerve using a TENS unit can affect reaction time. Participants get brief, painless ear stimulation and their reaction times are measured before and after.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: vagus nerve stimulationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Youngstown State University

Lead Sponsor

Trials
27
Recruited
2,000+

Citations

Non-invasive Cervical Vagus Nerve Stimulation Effects ... - PMC

This study revealed two major findings. First, when compared to sham, the nVNS group reaction time was consistently reduced for all (CPT, positive and negative) ...

Outcome and predictors of response to vagus nerve ... - PMC

Ten patients (18.9%) had a neuronal migration disorder. Over the 24 years, twelve patients discontinued VNS therapy, including four deaths, ...

Learnings from 30 years of reported efficacy and safety ...

In general, VNS efficacy becomes optimal around the sixth month of treatment and a 50–100 % seizure frequency reduction is achieved in approximately 45–65 % of ...

Long-term efficacy and safety of vagus nerve stimulation in ...

The efficacy of VNS during the first year of treatment has been demonstrated in clinical trials, with the key finding of increasing response and ...

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)

Safety: The primary objective of this study was to demonstrate that treatment with. VNS Therapy is safe for use over extended time periods. Historical efficacy: ...

Safety and tolerability of Transcutaneous Vagus Nerve ...

tVNS has been safe and well tolerated by research participants to date. · The most common side effect of tVNS was skin irritation (in 18.2%). · 35 (2.6%) tVNS ...

Safety of vagus nerve stimulation and responsive ...

This study demonstrated that RNS and VNS therapies can safely be used simultaneously in pediatric patients.