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NCT05602779 · ClinicalTrials.gov registry record · NA

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

A NA study of Suicidal Ideation and Self Harm, sponsored by University of Notre Dame.

Recruiting
Registry status
NA
Development phase
200
Enrollment target
2
Study locations

NCT05602779 is a NA study of Suicidal Ideation and Self Harm that is actively recruiting participants, run by University of Notre Dame. The registered enrollment target is 200 participants, below the 266-participant average among 84 other Suicidal Ideation trials with a reported enrollment target (25% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT05602779, a NA study of Suicidal Ideation and Self Harm, is actively recruiting participants, sponsored by University of Notre Dame.

RECRUITING
Registry status
NA
Development phase
200 participants
Enrollment target
2
Study locations

Study 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.

Interventions

  • DEVICE tVNS Program
  • OTHER Phone App Program
  • COMBINATION_PRODUCT tVNS and Phone App Program
  • OTHER Sham tNVS and Control App

Study Locations (2)

Indiana

  • University of Notre Dame - South Bend

New York

  • University of Rochester Medical Center - Rochester

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2024-11-15
Est. Completion 2027-09-30
Phase NA

Sponsor

University of Notre Dame

13 total trials

What the Registry Record Tells You About NCT05602779

The ClinicalTrials.gov registry entry for NCT05602779 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 266-participant average among 84 other Suicidal Ideation trials with a reported enrollment target (25% lower). The listed sponsor is University of Notre Dame, which has 13 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Suicidal Ideation appearing as the primary indexed condition, and to 4 interventions - of which tVNS Program is the first listed.

NCT05602779 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Indiana, New York.

Frequently Asked Questions

What is clinical trial NCT05602779 about?

NCT05602779 is a clinical study titled "Leverage Noninvasive Transcutaneous Vagus Nerve Stimulation to Reduce Suicidal Behaviors in Vulnerable Adolescents". 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 int...

What is the current status of trial NCT05602779?

This trial is currently recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2024-11-15. Estimated completion is 2027-09-30.

What conditions does trial NCT05602779 study?

This clinical trial studies the following conditions: Suicidal Ideation, Self Harm.

What interventions are being tested in trial NCT05602779?

The interventions under investigation include: tVNS Program (DEVICE), Phone App Program (OTHER), tVNS and Phone App Program (COMBINATION_PRODUCT), Sham tNVS and Control App (OTHER).

Who is sponsoring clinical trial NCT05602779?

This trial is sponsored by University of Notre Dame, which has 13 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05602779 being conducted?

This trial has 2 study locations across Indiana, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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