tVNS for Self-Harm and Substance Misuse
(TEAM Trial)
What You Need to Know Before You Apply
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.
Is transcutaneous vagus nerve stimulation (tVNS) safe for humans?
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.12678
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.3491011
Who Is on the 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
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive self-administered tVNS sessions daily for 25 minutes to reduce NSSI and alcohol misuse
Follow-up
Participants are monitored for maintenance of treatment effects and changes in emotion regulation
What Are the Treatments Tested in This Trial?
Interventions
- No Intervention
- Non-invasive Transcutaneous Nerve Stimulation (tVNS)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Notre Dame
Lead Sponsor