Vagus Nerve Stimulation in Children

Enrolling by invitation at 1 trial location

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Brain injury, Bradycardia, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 30 minutes

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study the safety and tolerability of transauricular vagus nerve stimulation (taVNS) in healthy children and to observe any changes in brain waves during treatment. Participants, already in the hospital for EEG monitoring, will receive a 30-minute session of taVNS. The trial focuses on children undergoing brain activity monitoring to understand certain spells or episodes. It excludes those with brain injuries, heart-related issues, or other specific medical conditions. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research in pediatric neurology.

Do I need to stop my current medications for this 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 transauricular vagus nerve stimulation is safe for children?

Research has shown that transauricular vagus nerve stimulation (taVNS) is generally safe for people. Studies have found it to be well-tolerated, especially compared to more invasive treatments. For children, this treatment is usually easy to handle.

Some mild and short-lasting side effects have been reported, but serious side effects are rare. The FDA has already approved vagus nerve stimulation for treating epilepsy in children, suggesting its safety. This background reassures that taVNS is designed to be safe, particularly because it is non-invasive and the stimulation is set to a level that cannot be felt. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transauricular Vagus Nerve Stimulation (taVNS) because it offers a new, non-invasive way to potentially influence brain activity in children. Unlike traditional treatments that might involve medication or more invasive procedures, taVNS uses gentle electrical impulses delivered through the ear to stimulate the vagus nerve, which could help modulate neurological functions. This approach is particularly appealing because it aims to be a safe and comfortable option for children, with the stimulation adjusted to stay below the level of perception, meaning kids won’t even feel it. Additionally, the use of EEG monitoring allows researchers to observe real-time changes in brain activity, providing valuable insights into how this treatment could work.

What evidence suggests that transauricular vagus nerve stimulation is effective for brain wave modulation in children?

Research has shown that stimulating the vagus nerve through the ear (taVNS) may help treat certain health issues. One study found that using taVNS for several months reduced seizures in a small group of patients. Another study demonstrated that taVNS could improve sleep quality for people with insomnia and alleviate related symptoms. In this trial, children will receive one session of taVNS to assess its tolerability and effects on EEG readings. Regarding safety, taVNS is well-tolerated in children, making it a more appealing option than invasive treatments. Although more research is needed, these early findings suggest taVNS could be a helpful treatment for various conditions. ^{4 6 7 8 9}

Who Is on the Research Team?

Alyssa Smith, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for healthy children who are undergoing clinical EEG at the investigator's institution to characterize spells. It excludes those with brain injury, heart issues like bradycardia or congenital heart disease, pregnancy, and those with a pacemaker or active cancer treatment.

Inclusion Criteria

Admitted for clinical EEG for spell characterization at investigator's institution

Exclusion Criteria

Pregnant

Pacemaker or wearable defibrillator

I was born with a heart condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Titration

Participants undergo a brief titration session where taVNS is titrated to below perceptual threshold

1 session

1 visit (in-person)

Treatment

Participants receive one session of 30 minutes of taVNS with continuous EEG and cardiorespiratory monitoring

30 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and tolerability after the taVNS session

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transauricular Vagus Nerve Stimulation

Trial Overview The study tests transauricular vagus nerve stimulation (taVNS) in kids to see if it's safe and how their bodies respond. It looks at changes in brain waves during taVNS using an EEG while also monitoring heart rate and blood pressure.

How Is the Trial Designed?

Group I: taVNS with EEG in healthy children Experimental Treatment 1 Intervention

The investigators will enroll 10 children between 7-18 years of age who are admitted to the hospital for EEG monitoring for spell characterization to receive one session of 30 minutes of taVNS. The investigators will titrate taVNS to below perceptual threshold of stimulation and objectively assess tolerability. The following parameters will be used for taVNS: frequency 25 Hz, pulse width 250 µs, and varying intensities from 0.5 milliampere (mA) to 2 mA. Intensity will be titrated to be a level below perceptual threshold in a patient. The participant will have continuous cardiorespiratory monitoring via pulse oximetry and blood pressure every 5 minutes. EEG data will be compared before, during and after taVNS.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

In a study of 24 children undergoing intermittent vagal nerve stimulation over a total of 61 patient years, 15 adverse events were reported, with 13 likely related to the device, indicating a need for careful monitoring during treatment.

Despite the occurrence of adverse events, vagal nerve stimulation was generally well tolerated, and unlike standard drug therapies, these events did not typically require stopping the treatment, although they sometimes led to unexpected surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in children receiving intermittent left vagal nerve stimulation. Murphy, JV., Hornig, GW., Schallert, GS., et al.[2019]

In a study of 60 Norwegian children with difficult-to-treat epilepsy, 72% reported positive effects from vagal nerve stimulation (VNS) after an average follow-up of 2.5 years, with 63% experiencing decreased seizure frequency or severity.

The side effects of VNS were generally mild, with 50% of patients reporting minor side effects, indicating that VNS is a relatively safe and effective additional treatment option for children with refractory epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Vagal nerve stimulation in children with drug-resistant epilepsy]. Bremer, A., Eriksson, AS., Røste, GK., et al.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10666166/

Use of non-invasive transcutaneous auricular vagus nerve ... This is the first study to investigate the long-term neurodevelopmental and sensory outcomes of children who as infants received taVNS paired ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8192665/

Transcutaneous Auricular Vagus Nerve Stimulation In two early studies with small sample sizes (10 and 14 cases), taVNS treatment lasting 6–9 months effectively reduced the frequency of seizure ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1094715922007644

Transcutaneous Auricular Vagus Nerve Stimulation in ... Compared with invasive vagus nerve stimulation, good safety and tolerability profiles also support the use of tVNS in pediatric patients. Potential ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06168071

Transauricular Vagus Nerve Stimulation in Children The goal of this clinical trial is to learn about brain waves during transauricular vagus nerve stimulation (taVNS) in healthy children.

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2828072

Transcutaneous Auricular Vagus Nerve Stimulation for ... Previous studies have demonstrated that taVNS cannot only effectively improve sleep quality in patients with insomnia, but also alleviate accompanying symptoms ...

6. nature.com nature.com/articles/s41598-022-25864-1

Safety of transcutaneous auricular vagus nerve stimulation ... Although taVNS is generally considered safe with only mild and transient adverse effects (AEs), those specifically caused by taVNS have not yet ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35995653/

Transcutaneous Auricular Vagus Nerve Stimulation in ... Compared with invasive vagus nerve stimulation, good safety and tolerability profiles also support the use of tVNS in pediatric patients.

8. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06168071

Transauricular Vagus Nerve Stimulation in Children VNS is FDA-approved for epilepsy therapy in children and is used for generalized refractory epilepsy. VNS may be achieved through an implantable stimulator on ...

9. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1418937/full

The efficacy and safety of bilateral synchronous ... Feasibility, safety and efficacy of transauricular vagus nerve stimulation in a cohort of patients with disorders of consciousness. Brain ...