Vagus Nerve Stimulation in Children

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

10 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn about brain waves during transauricular vagus nerve stimulation (taVNS) in healthy children. The main questions it aims to answer are: * What is the safety, tolerability, and physiological response of taVNS in children? * Does the electroencephalogram (EEG) change during taVNS? Participants will * undergo a brief titration session where taVNS will be titrated to below perceptual threshold * receive one session of 30 minutes of taVNS * undergo clinical EEG monitoring during taVNS * Continuous cardiorespiratory monitoring via pulse oximetry and blood pressure every 5 minutes * Answer tolerability questions before, during and after 30 minute taVNS session

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 data supports the effectiveness of the treatment Transauricular Vagus Nerve Stimulation in children?

Research shows that vagus nerve stimulation (VNS), including a similar method called transcutaneous auricular vagus nerve stimulation (ta-VNS), can be effective in reducing seizures in children with epilepsy, suggesting it may help with other conditions too. ^{1 2 3 4 5}

Is vagus nerve stimulation safe for children?

Vagus nerve stimulation in children has been generally well-tolerated, but some adverse events have been reported, such as voice changes, coughing, drooling, and increased hyperactivity. In some cases, these events required additional surgery, but they did not always lead to stopping the treatment. ^{2 6 7 8 9}

How is transauricular vagus nerve stimulation different from other treatments for this condition?

Transauricular vagus nerve stimulation is unique because it involves stimulating the vagus nerve through the ear, which is a non-invasive method compared to traditional treatments that might require surgery or medication. This approach can potentially offer a safer and more comfortable option for children, as it avoids the risks associated with more invasive procedures. ^{10 11 12 13 14}

Research Team

Alyssa Smith, MD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Vagal nerve stimulation in children under 12 years old with medically intractable epilepsy. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular vagus nerve stimulation as a complementary therapy for pediatric epilepsy: a pilot trial. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Outcomes of vagal nerve stimulation in a pediatric population: a single center experience. [2014]

4. Norway pubmed.ncbi.nlm.nih.gov

[Vagal nerve stimulation in children with drug-resistant epilepsy]. [2015]

5. Germany pubmed.ncbi.nlm.nih.gov

Vagus nerve stimulation in children with intractable epilepsy: indications, complications and outcome. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse events in children receiving intermittent left vagal nerve stimulation. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Vagus nerve stimulation therapy in pediatric patients with refractory epilepsy: retrospective study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Misidentification of vagus nerve stimulator for intravenous access and other major adverse events. [2008]

9. Denmark pubmed.ncbi.nlm.nih.gov

VNS therapy in clinical practice in children with refractory epilepsy. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Endoscopic Resection of Pediatric Skull Base Tumors: An Evidence-Based Review. [2020]

11. Germany pubmed.ncbi.nlm.nih.gov

Endoscopic Transnasal Skull Base Surgery in Pediatric Patients. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Outcome of Endoscopic Endonasal Surgery in Pediatric Craniopharyngiomas. [2020]

13. United States pubmed.ncbi.nlm.nih.gov

Suprasellar and recurrent pediatric craniopharyngiomas: expanding indications for the extended endoscopic transsphenoidal approach. [2019]

14. Germany pubmed.ncbi.nlm.nih.gov

Is there a place for the endoscope in skull base surgery in children less than 5 years? [2014]