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Search / Trial NCT05602779

Leverage Noninvasive Transcutaneous Vagus Nerve Stimulation to Reduce Suicidal Behaviors in Vulnerable Adolescents

Launched by UNIVERSITY OF NOTRE DAME · Nov 1, 2022

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Self Harm Suicide Prevention

ClinConnect Summary

This clinical trial is exploring new ways to help teenagers who struggle with thoughts of self-harm and suicide. The researchers want to see if two innovative treatments can make a difference: one involves a noninvasive method called transcutaneous vagus nerve stimulation, which helps with emotional regulation, and the other is a peer-support smartphone app designed to reduce feelings of social isolation. By using these digital approaches, they hope to reach more young people effectively and at a lower cost than traditional methods.

To be eligible for the trial, participants must be between 13 and 17 years old and attend in-person meetings in South Bend, IN, or Rochester, NY. They should have experienced self-harm or display high levels of emotional struggles, isolation, impulsivity, or depression. It’s important to note that individuals with certain medical conditions, such as autism, schizophrenia, or those who have implanted devices like pacemakers, cannot participate. Those who join can expect to engage in the treatments and contribute to valuable research that aims to improve mental health support for adolescents.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Aged between 13 and 17 years,
  • Daily access to a smartphone
  • Attend in person meetings in South Bend, IN or Rochester, NY. and,
  • Two of the following which will be scored during the phone screen:
  • High scores on social isolation
  • High scores on emotion dysregulation
  • Has engaged in NSSI (inclusive of a single act)
  • High T-scores on impulsivity,
  • High T-scores on depression
  • Engages in alcohol or other substance use
  • Exclusion Criteria:
  • Parent reported autism or schizophrenia
  • Implanted pacemaker or cardiac defibrillator, other implanted or metallic device
  • Pregnant or breast feeding
  • History of seizures or epilepsy
  • TMJ Disorder
  • Bells' Palsy
  • Impaired cranial nerve function
  • Facial Pain

About University Of Notre Dame

The University of Notre Dame is a prestigious research institution dedicated to advancing knowledge and improving health outcomes through innovative clinical trials. Committed to excellence in research and education, the university leverages its interdisciplinary expertise and state-of-the-art facilities to conduct rigorous clinical studies that address pressing medical challenges. With a focus on ethical practices and participant safety, the University of Notre Dame collaborates with healthcare professionals and community partners to translate scientific discoveries into effective therapies, ultimately enhancing patient care and contributing to the broader field of medical research.

Locations

Rochester, New York, United States

South Bend, Indiana, United States

Patients applied

0 patients applied

Trial Officials

Kristin Valentino, PhD

Principal Investigator

University of Notre Dame

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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