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

Summary

Suicidal thoughts, suicide attempts, and suicide are increasingly common in adolescence.

Current face-to-face prevention approaches are of limited effectiveness, rely on extensive resources, and are at odds with adolescents' digital preferences. We will evaluate two unconventional but promising interventions delivered to 13- to 17-year-olds: transcutaneous vagus nerve stimulation to target emotion dysregulation, and a peer-support smartphone app to combat social isolation. If effective, these digitally-delivered interventions could reach far more adolescents at far lower cost than current approaches.

Conditions

• Self Harm
• Suicidal Ideation

Interventions

DEVICE

tVNS Program

Participants will use the Neuvana Xen device 30 minutes a day for 30 days. The device delivers stimulation through the left ear via an ear bud. Participants can use the device at any time of day.

OTHER

Phone App Program

Participants will have access to a specially designed phone app (MindTiles) in order to play a game designed for this study. Participants in the active intervention will be able to connect with a fellow participant who is matched as their peer for social support and they will complete a daily puzzle together and respond to a conversational prompt to encourage communication.

COMBINATION_PRODUCT

tVNS and Phone App Program

Participants will have both the Neuvana Xen Device and the full version of our program's phone app. They will use the device and full app access for 30 days.

OTHER

Sham tNVS and Control App

Participants will have access to our program's phone app so the can complete the daily puzzle on their own. They will also engage in a sham tVNS session for 30min per day for 30 days during which no stimulation is provided.

Sponsors & Collaborators

• University of Rochester

  collaborator OTHER

• University of Wisconsin, Madison

  collaborator OTHER

• University of Notre Dame

  lead OTHER

Principal Investigators

• Kristin Valentino, PhD · University of Notre Dame

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

13 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-15

Primary Completion

2027-04-15

Completion

2027-09-30

FDA Device

Yes

Countries

• United States

Study Locations