tVNS for Self-Harm and Substance Misuse

(TEAM Trial)

Overseen By Theodore P Beauchaine, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Notre Dame

Disqualifiers: Autism, Schizophrenia, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called transcutaneous vagus nerve stimulation (tVNS) to determine its effectiveness in reducing self-harm and alcohol misuse in adolescents. The goal is to offer a low-cost, accessible option for those lacking access to traditional therapy, particularly in rural areas or among disadvantaged groups. Participants will either receive a tVNS device (a non-invasive nerve stimulation device) or not, to compare the effects. Teens who have used alcohol and experienced multiple instances of self-harm may be suitable candidates for this study. As an unphased trial, this study allows participants to contribute to important research that could lead to more accessible mental health treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this device is safe for adolescents?

Research has shown that transcutaneous vagus nerve stimulation (tVNS) is generally safe and well-tolerated. Most studies report only mild and short-term side effects. For instance, about 18.2% of participants experienced skin irritation. More serious side effects are uncommon, affecting only 2.6% of participants. Overall, tVNS seems to be a safe choice for most individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using non-invasive Transcutaneous Vagus Nerve Stimulation (tVNS) for self-harm and substance misuse because it offers a unique approach compared to traditional treatments like medication and therapy. tVNS works by stimulating the vagus nerve through the skin, which can potentially regulate mood and addiction-related behaviors without the need for drugs. This method is appealing because it avoids the side effects often associated with medications, providing a promising alternative for individuals who may not respond well to conventional treatments. Additionally, its non-invasive nature makes it easy and convenient to use, potentially improving adherence and outcomes.

What evidence suggests that this tVNS is effective for reducing self-harm and substance misuse?

Research shows that transcutaneous vagus nerve stimulation (tVNS) might help with various health issues. Studies have found that tVNS can ease symptoms for people experiencing opioid withdrawal and improve sleep for those with insomnia. One study found that tVNS can enhance certain brain functions, such as controlling responses, which might be important for managing behaviors related to self-harm and substance use. In this trial, participants in the treatment group will receive a tVNS device to explore its potential benefits for teenagers dealing with self-harm and alcohol misuse. The non-treatment group will not receive a tVNS device. More research is needed to confirm its effectiveness for these specific issues. ^{3 5 6 7 8}

Who Is on the Research Team?

Theodore P Beauchaine, PhD

Principal Investigator

University of Notre Dame

Brooke A Ammerman, PhD

Principal Investigator

University of Notre Dame

Kristin Valentino, PhD

Principal Investigator

University of Notre Dame

Are You a Good Fit for This Trial?

This trial is for adolescents who have self-harmed at least three times in the past six months or five times in their life, with one incident within the last year. They must also have used alcohol and own a smartphone. It's not suitable for those with autism, schizophrenia, cardiac devices, pregnancy, seizure history, Bell's Palsy, cranial nerve issues or TMJ disorder.

Inclusion Criteria

Have engaged in ≥ 3 episodes of NSSI in the past 6 months or ≥ 5 lifetime (1 of these 5 must be in the past year)

Have used alcohol

Own a smartphone (iPhone or Android)

Exclusion Criteria

I have a history of seizures or epilepsy.

I have jaw joint pain or dysfunction.

I experience facial pain or issues with my facial nerve function.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive self-administered tVNS sessions daily for 25 minutes to reduce NSSI and alcohol misuse

4 weeks

Daily self-administered sessions

Follow-up

Participants are monitored for maintenance of treatment effects and changes in emotion regulation

3 months

What Are the Treatments Tested in This Trial?

Interventions

• No Intervention
• Non-invasive Transcutaneous Nerve Stimulation (tVNS)

Trial Overview The TEAM trial is testing non-invasive transcutaneous vagus nerve stimulation (tVNS) as a potential low-cost treatment to reduce risks of nonsuicidal self-injury and substance misuse among vulnerable adolescents compared to no intervention.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 Intervention

Participants will receive a tVNS device.

Group II: Non-Treatment Group Experimental Treatment 1 Intervention

Participants will not receive a tVNS device.

Who Is Running the Clinical Trial?

University of Notre Dame

Lead Sponsor

Trials

36

Recruited

60,000+

Published Research Related to This Trial

Transcutaneous vagus nerve stimulation (tVNS) was found to significantly increase salivary alpha amylase (SAA) levels and reduce the decline of salivary cortisol in healthy participants, indicating a modulation of hormonal indices related to noradrenergic function.

However, tVNS did not show any significant effects on psychophysiological measures such as P3 amplitude or pupil size, suggesting that while it may influence hormonal responses, it does not impact certain cognitive or physiological indices in the same way.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The neuromodulatory and hormonal effects of transcutaneous vagus nerve stimulation as evidenced by salivary alpha amylase, salivary cortisol, pupil diameter, and the P3 event-related potential. Warren, CM., Tona, KD., Ouwerkerk, L., et al.[2019]

Transcutaneous vagus nerve stimulation (tVNS) shows promise for treating various conditions in pediatric patients, but current studies lack specific protocols and justification for its use in this age group, as none of the 15 identified studies focused exclusively on children.

There are no dedicated tVNS devices for pediatric use, and existing studies do not adequately address neurodevelopmental considerations, highlighting the need for more research on age-appropriate stimulation parameters and protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Auricular Vagus Nerve Stimulation in Pediatric Patients: A Systematic Review of Clinical Treatment Protocols and Stimulation Parameters. Sigrist, C., Torki, B., Bolz, LO., et al.[2023]

Transcutaneous vagus nerve stimulation (TVNS) significantly reduced perceived pain intensity during heat stimulation compared to no intervention, with a notable hypoalgesic effect especially in men before the onset of temporal summation of pain (TSP).

In women, TVNS also decreased the TSP response compared to no intervention, but overall, the effects of TVNS were comparable to those of placebo and sham stimulation, indicating that while TVNS shows promise, its efficacy may vary by gender.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Electrical Transcutaneous Vagus Nerve Stimulation on the Perceived Intensity of Repetitive Painful Heat Stimuli: A Blinded Placebo- and Sham-Controlled Randomized Crossover Investigation. Janner, H., Klausenitz, C., Gürtler, N., et al.[2019]

The FDA has approved two non-invasive electrical nerve stimulators that can help alleviate acute opioid withdrawal symptoms by stimulating cranial nerves behind the ear, showing promise as an adjunct treatment.

This method of auricular electrical neural stimulation has the potential to enhance medication-assisted treatment for opioid detoxification, offering lower side effects and potentially improving patient adherence to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auricular neural stimulation as a new non-invasive treatment for opioid detoxification. Qureshi, IS., Datta-Chaudhuri, T., Tracey, KJ., et al.[2021]

A systematic review of 26 randomized sham-controlled trials suggests that non-invasive brain stimulation (NIBS) may effectively reduce cravings and improve cognitive functions in patients with alcohol and tobacco use disorders.

NIBS shows promise as a new treatment approach for substance use disorders, indicating its potential therapeutic effects in managing addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of Non-Invasive Brain Stimulation in Substance Use Disorders: A Review of Randomized Sham-Controlled Clinical Trials. Trojak, B., Sauvaget, A., Fecteau, S., et al.[2018]

Auricular transcutaneous vagus nerve stimulation (atVNS) may enhance the effectiveness of methadone maintenance treatment (MMT) for opioid use disorder (OUD) by improving mood and cognitive control, which are often impaired in individuals with OUD.

atVNS is culturally accepted in China and offers practical advantages such as ease of use and the ability for at-home self-administration, making it a promising adjunct therapy for those undergoing treatment for opioid withdrawal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regaining control over opioid use? The potential application of auricular transcutaneous vagus nerve stimulation to improve opioid treatment in China. Colzato, L., Elmers, J., Xu, X., et al.[2023]

Noninvasive brain stimulation (NIBS) shows potential as a novel treatment strategy for opioid use disorder (OUD), but current research is limited, with only five studies involving a total of 150 participants identified in a systematic review.

The studies utilized various NIBS techniques, including TMS and tDCS, to target issues like cue-induced craving and withdrawal symptoms, indicating that while promising, more extensive research is needed to fully understand the efficacy and mechanisms of NIBS in treating OUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Noninvasive Brain Stimulation for Opioid Use Disorder. Ward, HB., Mosquera, MJ., Suzuki, J., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9588751/

Transcutaneous cervical vagus nerve stimulation reduces ... Transcutaneous cervical vagus nerve stimulation reduces behavioral and physiological manifestations of withdrawal in patients with opioid use disorder.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06510985

Transcutaneous Vagus Nerve Stimulation (tVNS) for ... In the proposed study, the investigators aim to investigate the effectiveness of transcutaneous vagus nerve stimulation (tVNS) as a non-invasive ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11543756/

Vagus nerve stimulation (VNS): recent advances and future ... Specifically, the high-frequency group experienced a 25% reduction in seizures, while the low-frequency group's seizures decreased by 6%.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666956025000364

Exploring the impact of transcutaneous vagus nerve ... Active tVNS resulted in partly accelerated neural processing in the context of response inhibition in both groups and enhanced EF performance in subjects ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2828072

Transcutaneous Auricular Vagus Nerve Stimulation for ... In this randomized clinical trial, taVNS significantly reduced insomnia severity. Clinically meaningful enhancements in PSQI scores were observed compared with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9772204/

Safety of transcutaneous auricular vagus nerve stimulation ... Although taVNS is generally considered safe with only mild and transient adverse effects (AEs), those specifically caused by taVNS have not yet ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1935861X18302936

Safety and tolerability of Transcutaneous Vagus Nerve ... tVNS has been safe and well tolerated by research participants to date. · The most common side effect of tVNS was skin irritation (in 18.2%). · 35 (2.6%) tVNS ...

8. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2025.1539416/full

A pooled analysis of the side effects of non-invasive ... These findings demonstrate a favorable safety profile of taVNS, with mostly mild and transient effects, supporting its use as a suitable non-invasive tool.