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Can a nerve zap and a phone app stop teen suicide?

NCT ID NCT05602779

Symptom relief Sponsor: University of Notre Dame Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests two new ways to help teens aged 13-17 who have suicidal thoughts or self-harm. One uses a small device that gently stimulates a nerve in the ear to help control emotions. The other is a smartphone app that connects teens with a supportive peer. The goal is to see if these approaches reduce suicidal thoughts and behaviors over one year.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

13 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Self-Injurious Behavior Suicidal Ideation Suicide Prevention

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Self harm Suicidal ideation

Contacts and locations

Locations

  • University of Notre Dame

    South Bend, Indiana, 46617, United States

  • University of Rochester Medical Center

    Rochester, New York, 14620, United States

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