Self HarmNCT05602779
Leverage Noninvasive Transcutaneous Vagus Nerve Stimulation to Reduce Suicidal Behaviors in Vulnerable Adolescents
A study testing tVNS Program, Phone App Program and tVNS and Phone App Program in people with Self Harm and Suicidal Ideation, run by University of Notre Dame at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Self Harm, Suicidal Ideation
- What is being tested?
- tVNS Program, Phone App Program and tVNS and Phone App Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Nov 2024to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Rochester Medical Center
Rochester, New York, 14620
University of Notre Dame
South Bend, Indiana, 46617
About this study
Official title: Leveraging Noninvasive Transcutaneous Vagus Nerve Stimulation and Smartphone Technology to Reduce Suicidal Behaviors and Suicide Among Highly 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 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.
Read the 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:
- tVNS to target emotion dysregulation,
- a peer-support phone app to target social isolation,
- tVNS + a peer-support phone app, or
- 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
- Being tested
- tVNS Program, Phone App Program, tVNS and Phone App Program, Sham tNVS and Control App
- Keywords
- Self Harm, Suicide Prevention
- Medical subject headings
- Self-Injurious Behavior, Suicidal Ideation, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tVNS ProgramDevice
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.
Phone App ProgramOther
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.
tVNS and Phone App ProgramCombination 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.
Sham tNVS and Control AppOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Sham tNVS and Control App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 Days; One Year
Secondary outcomes (2)
Change from Baseline to Follow-up Assessments in Emotion Dysregulation
Some teens will be randomized to the active tVNS condition where they will receive daily stimulation to their vagus nerve, which should modulate emotion dysregulation. Each participating teen will complete questionnaires regarding emotion dysregulation on the Qualtrics survey (Difficulties in Emotion Regulation Scale (DERS)) at all timepoints. We anticipate those who are randomized to the active tVNS condition will show improvement in emotion dysregulation at 30 days and one year post treatment relative to the other treatment arms, as well as show improved within-person change.
Measured: 30 Days; One Year
Change from Baseline to Follow-up Assessments in Social Connection and Loneliness
Some teens will be assigned to using the peer support phone app where they will be matched with another teen in the study. They will play a cooperative game with each other, and be able to text and share thoughts, feelings, etc. with each other during the 30 days intervention period. The peer-matched MindTiles app is expected to improve teen's self-reported feelings of isolation and loneliness.
Each participating teen will complete questions regarding feelings of loneliness and social isolation on the Qualtrics survey during all lab visits. We are using the 3 Item UCLA Loneliness scale and the INQ-15. We plan to examine between group change across treatment groups as well as within-person change at 30 days and one year post intervention.
Measured: 30 Days; One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start15 Nov 2024
- Primary completion15 Apr 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self HarmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be four distinct treatment groups, each participant will be randomly assigned to one of the four groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Notre Dame
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rochester, University of Wisconsin, Madison
- Responsible party
- Principal investigator, Kristin Valentino, University of Notre Dame
- Investigators
- Kristin Valentino, PhD, Principal investigator, University of Notre Dame
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602779
- Sponsor's protocol ID
- 22-08-7372
- Status last verified
- Apr 2026
- First submitted
- 6 Oct 2022
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share individual participant data outside of the study team.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Noninvasive Transcutaneous Vagus Nerve Stimulation and Smartphone Technology to Reduce Suicidal Behaviors and Suicide Among Highly Vulnerable Adolescents
- ClinicalTrials.gov ID
- NCT05602779
- Acronym / sponsor ID
- 22-08-7372
- Conditions
- Self Harm, Suicidal Ideation
- Keywords
- Self Harm, Suicide Prevention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Notre DameUniversity, hospital or other
- Collaborators
- University of Rochester, University of Wisconsin, Madison
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- tVNS to target emotion dysregulation,
- a peer-support phone app to target social isolation,
- tVNS + a peer-support phone app, or
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- There will be four distinct treatment groups, each participant will be randomly assigned to one of the four groups.
| Arm | Type | Receives |
|---|---|---|
| tVNS Program + Control app | Experimental | Device: tVNS ProgramAdolescents 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. |
| Phone App Program + Sham tVNS | Experimental | Other: Phone App ProgramAdolescents 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. |
| tVNS and Phone App Program | Experimental | Combination Product: tVNS and Phone App ProgramAdolescents 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. |
| Sham tVNS + Control App | Sham comparator | Other: Sham tNVS and Control AppAdolescents 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. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Aged between 13 and 17 years,
- Daily access to a smartphone
- Attend in person meetings in South Bend, IN or Rochester, NY. and,
- High scores on social isolation
- High scores on emotion dysregulation
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tVNS ProgramParticipants 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. | Device | tVNS Program + Control app |
| Phone App ProgramParticipants 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. | Other | Phone App Program + Sham tVNS |
| tVNS and Phone App ProgramParticipants 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. | Combination product | tVNS and Phone App Program |
| Sham tNVS and Control AppParticipants 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. | Other | Sham tVNS + Control App |
Primary outcome
Changes from Baseline to Follow-up Assessments in Self-Injurious Thoughts and Behaviors over one year
Time frame: 30 Days; 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.
2 secondary outcomes
Change from Baseline to Follow-up Assessments in Emotion Dysregulation
Time frame: 30 Days; One Year
Change from Baseline to Follow-up Assessments in Social Connection and Loneliness
Time frame: 30 Days; One Year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data outside of the study team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin Valentino, PhD principal investigator
University of Notre Dame
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tVNS Program, Phone App Program and tVNS and Phone App Program in people with Self Harm and Suicidal Ideation, run by University of Notre Dame at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from Baseline to Follow-up Assessments in Self-Injurious Thoughts and Behaviors over one year (time frame: 30 Days; One Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.