NCT05602779

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

Leveraging Noninvasive Transcutaneous Vagus Nerve Stimulation and Smartphone Technology to Reduce Suicidal Behaviors and Suicide Among Highly Vulnerable Adolescents

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of Notre Dame · Academic / Other
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Over the past two decades, suicide rates have increased nearly 35% in the U.S., with upward trends in nearly all demographic groups. Further increases have occurred since the COVID-19 pandemic began. Despite ambitious goals for reducing suicides and significant federal and private investment, suicide rates continue to rise unabated. To date, the predominant approach to mitigating suicide risk in the U.S. is secondary prevention. Typically, these programs identify risk of recurrence among those who have already attempted suicide at least once. Although secondary prevention is crucial, the majority of deaths by suicide occur on first attempt. Thus, targeted primary prevention earlier in development is essential. Most current primary prevention programs are intensive, expensive, and delivered by highly trained mental health providers, who are in short supply. Traditional face-to-face therapy is also unavailable to many who live in underserved communities, and disliked by adolescents, who much prefer digital delivery on their devices. This high-risk, high-reward proposal addresses these limitations and needs. We use an experimental therapeutics approach to evaluate the independent and combined efficacies of two unconventional but scalable interventions: transcutaneous vagus nerve stimulation (tVNS) to target emotion dysregulation, and a peer-support smartphone app to combat social isolation. These low-cost interventions, which hold strong promise but have not been used before, can reach large numbers of adolescents, with much potential to reduce prospective suicide risk. We will enroll 212 adolescents, ages 13-17 years, who show elevations on at least two prominent risk factors for suicide (e.g., self-injury, maltreatment). Using a 2 × 2 design, adolescents will be assigned randomly to receive 30 days of treatment with: 1. tVNS to target emotion dysregulation, 2. a peer-support phone app to target social isolation, 3. tVNS + a peer-support phone app, or 4. enhanced treatment as usual with monitoring and access to resources. Intervention effects on mechanisms (emotion dysregulation, social isolation) proximal efficacy signals (e.g., physiological reactivity, self-harm) and target outcomes (suicidal ideation, suicidal behaviors) will be evaluated immediately post-intervention and at one-year follow-up. Treatment data will be monitored daily to fine-tune dosing of both interventions. This transformative and innovative proposal tests two novel, scalable preventive interventions designed to "meet adolescents where they are" by using digital technologies to address core mechanisms of suicide risk.

Conditions

• Self Harm
• Suicidal Ideation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-11-15
• Primary completion: 2027-04-15
• Completion: 2027-09-30
• First posted: 2022-11-02
• Last updated: 2026-04-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study