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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if a device that sends mild electrical signals to a nerve in the neck can help vulnerable teens who hurt themselves or misuse alcohol. The treatment aims to calm their nervous system and improve their emotional control.

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 data supports the effectiveness of the treatment Non-invasive Transcutaneous Nerve Stimulation (tVNS) for self-harm and substance misuse?

Research suggests that non-invasive nerve stimulation, like tVNS, may help with substance use disorders by reducing withdrawal symptoms and cravings, as seen in studies on opioid detoxification. While more research is needed, these findings indicate potential benefits for managing substance misuse. ^{1 2 3 4 5}

Is transcutaneous vagus nerve stimulation (tVNS) safe for humans?

Transcutaneous vagus nerve stimulation (tVNS) is considered a safe and non-invasive treatment option, as evidenced by its use in various conditions like major depressive disorder and opioid withdrawal, with reports of low side effects and good adherence to treatment. ^{1 3 6 7 8}

How is the treatment tVNS unique for self-harm and substance misuse?

tVNS is a unique treatment because it is non-invasive and works by stimulating the vagus nerve through the skin, which may help regulate mood and reduce cravings by increasing certain brain chemicals. Unlike other treatments, it does not require surgery or medication, making it a potentially safer and more accessible option. ^{6 7 9 10 11}

Research Team

Theodore P Beauchaine, PhD

Principal Investigator

University of Notre Dame

Kristin Valentino, PhD

Principal Investigator

University of Notre Dame

Brooke A Ammerman, PhD

Principal Investigator

University of Notre Dame

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Synchronised transcranial magnetic stimulation for substance use-disordered Veterans: protocol for the pilot sham-controlled acceptability trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of Noninvasive Brain Stimulation for Opioid Use Disorder. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Auricular neural stimulation as a new non-invasive treatment for opioid detoxification. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

[Clinical effects of non-invasive neuromodulation techniques in substance use disorder: an overview]. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Non-invasive brain stimulation modalities for the treatment and prevention of opioid use disorder: a systematic review of the literature. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Effect and neural mechanisms of the transcutaneous vagus nerve stimulation for relapse prevention in patients with remitted major depressive disorder: protocol for a longitudinal study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Outcome of Non-Invasive Brain Stimulation in Substance Use Disorders: A Review of Randomized Sham-Controlled Clinical Trials. [2018]

8. United States 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. [2023]

9. United States 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. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous Auricular Vagus Nerve Stimulation in Pediatric Patients: A Systematic Review of Clinical Treatment Protocols and Stimulation Parameters. [2023]

11. United States 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. [2019]