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

NCT05602779 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 22-08-7372
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Self Harm; Suicide Prevention

Outcome Measures

Primary Outcomes (1)

• Changes from Baseline to Follow-up Assessments in Self-Injurious Thoughts and Behaviors over one year

  Teens will be assessed at baseline visits for self-injurious thoughts and behaviors (non-suicidal self-injury (NSSI), suicidal ideation (SI), suicide attempts (SA)). They will complete measures individually on the Qualtrics Survey (SIQ) as well as participate in a face-to-face interview with a trained staff member to assess their level of NSSI, SI, and SA (CSSRS, DSHI). All participants will repeat these tasks at all visits (post-treatment, one-year follow-up). We expect teens who have used the active tVNS device will show improved responses (e.g., decreases in NSSI and SI). Teens who have engaged in the peer-matched MindTiles condition will show improved responses in SI, SA, and NSSI. For both conditions we will examine rates of self-injurious thoughts and behaviors in the treatment arms in relation to national norms. We plan to examine between group change across treatment groups as well as within-person change at 30 days and one year post intervention.

  30 Days; One Year

Secondary Outcomes (2)

• Change from Baseline to Follow-up Assessments in Emotion Dysregulation

  30 Days; One Year

• Change from Baseline to Follow-up Assessments in Social Connection and Loneliness

  30 Days; One Year

Study Arms (4)

tVNS Program + Control app

EXPERIMENTAL

Adolescents will self-administer 30-minute tVNS (i.e., nerve stimulation) sessions daily for 30 days. They will receive a daily text message on their phone to remind them about their session. They will have access to MindTiles where they will complete daily puzzles on their own. In addition, they will answer a 2-3 minute self-report survey on their current thoughts, feelings, and behaviors once a day for 30 days. They will receive a text message with a link to Qualtrics, a secure online platform where they will complete the survey.

Device: tVNS Program

Phone App Program + Sham tVNS

EXPERIMENTAL

Adolescents will use a specially designed phone app (MindTiles) to communicate with peer to help them cope with emotions, and to foster connection with peers to establish social connections. In addition, they will answer a 2-3 minute self-report survey on their current thoughts, feelings, and behaviors once a day for 30 days. They will receive a text message with a link to Qualtrics, a secure online platform where they will complete the survey. Adolescents will also self-administer 30-minute sham tVNS (i.e., nerve stimulation) sessions daily for 30 days; these sessions will include no actual stimulation.

Other: Phone App Program

tVNS and Phone App Program

EXPERIMENTAL

Adolescents will self-administer 30-minute tVNS (i.e., nerve stimulation) sessions daily for 30 days. Adolescents will also use a specially designed phone app (MindTiles) to communicate with a peer to help them cope with emotions, and to foster connection with peers to establish social connections. They will receive a daily text message on their phone to remind them about their session. In addition, they will answer a 2-3 minute self-report survey on their current thoughts, feelings, and behaviors once a day for 30 days. They will receive a text message with a link to Qualtrics, a secure online platform where they will complete the survey.

Combination Product: tVNS and Phone App Program

Sham tVNS + Control App

SHAM COMPARATOR

Adolescents will self-administer 30-minute sham tVNS (i.e., nerve stimulation) sessions daily for 30 days; these sessions will include no actual stimulation.They will receive a daily text message on their phone to remind them about their session. They will also have access to MindTiles where they will complete daily puzzles on their own. They will answer a 2-3 minute self-report survey on their current thoughts, feelings, and behaviors once a day for 30 days. They will receive a text message with a link to Qualtrics, a secure online platform where they will complete the survey.

Other: Sham tNVS and Control App

Interventions

tVNS Program DEVICE

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.

tVNS Program + Control app

Phone App Program OTHER

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.

Phone App Program + Sham tVNS

tVNS and Phone App Program COMBINATION_PRODUCT

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.

tVNS and Phone App Program

Sham tNVS and Control App OTHER

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.

Sham tVNS + Control App

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Notre Dame: lead
• University of Rochester: collaborator
• University of Wisconsin, Madison: collaborator

Study Sites (2)

University of Notre Dame

South Bend, Indiana, 46617, United States

Location

University of Rochester Medical Center

Rochester, New York, 14620, United States

Location

MeSH Terms

Conditions

Self-Injurious Behavior; Suicidal Ideation; Suicide Prevention

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Suicide

Study Officials

• Kristin Valentino, PhD

  University of Notre Dame

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Model Details: There will be four distinct treatment groups, each participant will be randomly assigned to one of the four groups.

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: November 2, 2022
• Study Start: November 15, 2024
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)