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Behavioural Intervention
tVNS for Self-Harm and Substance Misuse (TEAM Trial)
N/A
Recruiting
Led By Brooke A Ammerman, PhD
Research Sponsored by University of Notre Dame
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
TEAM Trial Summary
This trial will study whether a noninvasive treatment for depression, transcutaneous vagus nerve stimulation (tVNS), is effective in reducing risk for nonsuicidal self-injury (NSSI) and substance misuse among vulnerable adolescents.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While tVNS is generally considered safe, potential side effects may include mild discomfort at the site of stimulation, headache, fatigue or slight dizziness. However specific side effects related to this study are not detailed.
TEAM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline in Emotion Regulation at Day 30
Change from Baseline in Non-suicidal Self Injury and Alcohol Misuse Behaviors at Day 30
Maintenance of Treatment Effects at 3 Months Post Intervention
Secondary outcome measures
Adherence to tVNS Intervention from Baseline to Day 30
TEAM Trial Design
2Treatment groups
Experimental Treatment
Group I: Treatment GroupExperimental Treatment1 Intervention
Participants will receive a tVNS device.
Group II: Non-Treatment GroupExperimental Treatment1 Intervention
Participants will not receive a tVNS device.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
No Intervention
2017
Completed Phase 1
~4840
Find a Location
Who is running the clinical trial?
University of Notre DameLead Sponsor
33 Previous Clinical Trials
61,544 Total Patients Enrolled
Brooke A Ammerman, PhDPrincipal InvestigatorUniversity of Notre Dame
Kristin Valentino, PhDPrincipal InvestigatorUniversity of Notre Dame
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have been diagnosed with Bell's Palsy.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Group
- Group 2: Non-Treatment Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any individuals beyond the age of fifty eligible for participation in this experiment?
"This research project is calling for adolescents aged 13 - 17 to participate."
Answered by AI
Does my profile match the criteria for this experiment?
"This study is recruiting around 50 participants between the ages of 13 and 17, who have previously been exposed to acoustic stimulation."
Answered by AI
Are there any opportunities for participants to join this clinical experiment?
"The information hosted on clinicaltrials.gov indicates that this medical trial is not presently accepting applicants, having been first posted on May 1st 2022 and last edited April 18th 2022. Nevertheless, there are 319 other ongoing studies recruiting patients at present."
Answered by AI
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