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

NARecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

November 15, 2024

Primary Completion Date

April 15, 2027

Study Completion Date

September 30, 2027

Conditions
Self HarmSuicidal 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.

Trial Locations (2)

14620

RECRUITING

University of Rochester Medical Center, Rochester

46617

RECRUITING

University of Notre Dame, South Bend

All Listed Sponsors
collaborator

University of Rochester

OTHER

collaborator

University of Wisconsin, Madison

OTHER

lead

University of Notre Dame

OTHER