CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Non-invasive Transcutaneous Nerve Stimulation (tVNS) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05343039
NCT05343039N/ACompleted

Leveraging Biomarkers and New Technologies to Reduce Self-Injury and Substance Abuse Risk Among Highly Vulnerable Adolescents

University of Notre Dame·interventional·Posted Apr 25, 2022·Updated Aug 17, 2025

In Brief

A clinical study evaluating Non-invasive Transcutaneous Nerve Stimulation (tVNS) and No Intervention for Nonsuicidal Self Injury and 2 related conditions. Completed, enrolled 30 participants across 1 site.

Detailed Summary

Adolescent nonsuicidal self-injury (NSSI) and alcohol misuse, alone and especially in combination, portend significant functional impairment in adulthood (e.g., relationship dysfunction, depression, suicidality). Although psychosocial interventions for NSSI and substance use are effective for some, they are also expensive and require highly trained clinicians. Treatment is therefore often unavailable to disadvantaged adolescents and those who live rurally. Thus, lower-cost alternative treatments are needed. We will evaluate the efficacy of noninvasive transcutaneous vagus nerve stimulation (tVNS), an effective treatment for depression, in reducing risk for NSSI and substance misuse among vulnerable adolescents.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedApr 25, 2022
Enrollment StartSep 6, 2022
Primary CompletionJan 15, 2025
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 4.2 years ago

Interventions

Non-invasive Transcutaneous Nerve Stimulation (tVNS)device

Participants will engage in 25-minute tVNS sessions every day for 30 days.

No Interventiondevice

Participants will not receive any intervention.