Study Summary
This trial is testing a new, non-invasive treatment for ADHD in children. It is looking at whether the treatment works and whether it is better than a sham treatment. It is also looking at how the treatment affects the brain and whether there are predictors of who will respond to the treatment.
- Attention Deficit Hyperactivity Disorder (ADHD)
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 14 Secondary · Reporting Duration: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 16, 20
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Active eTNS
1 of 2
Sham eTNS
1 of 2
Experimental Treatment
Non-Treatment Group
280 Total Participants · 2 Treatment Groups
Primary Treatment: Active eTNS · Has Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 7 - 12 · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- McGough, James J., Sandra K. Loo, and Ian A. Cook. 2019. “Reply to “transcutaneous Electric Currents to Target the Peripheral and Central Nervous System in Children with Attention Deficit Hyperactivity Disorder””. Clinical Neurophysiology. Elsevier BV. doi:10.1016/j.clinph.2019.07.012.
- Loo, Sandra K., Giulia C. Salgari, Alissa Ellis, Jennifer Cowen, Andrea Dillon, and James J. McGough. 2021. “Trigeminal Nerve Stimulation for Attention-deficit/hyperactivity Disorder: Cognitive and Electroencephalographic Predictors of Treatment Response”. Journal of the American Academy of Child & Adolescent Psychiatry. Elsevier BV. doi:10.1016/j.jaac.2020.09.021.
- McGough, James J., Alexandra Sturm, Jennifer Cowen, Kelly Tung, Giulia C. Salgari, Andrew F. Leuchter, Ian A. Cook, Catherine A. Sugar, and Sandra K. Loo. 2019. “Double-blind, Sham-controlled, Pilot Study of Trigeminal Nerve Stimulation for Attention-deficit/hyperactivity Disorder”. Journal of the American Academy of Child & Adolescent Psychiatry. Elsevier BV. doi:10.1016/j.jaac.2018.11.013.
- McGough, James J., Sandra K. Loo, Alexandra Sturm, Jennifer Cowen, Andrew F. Leuchter, and Ian A. Cook. 2015. “An Eight-week, Open-trial, Pilot Feasibility Study of Trigeminal Nerve Stimulation in Youth with Attention-deficit/hyperactivity Disorder”. Brain Stimulation. Elsevier BV. doi:10.1016/j.brs.2014.11.013.
- McGough JJ, Loo SK, Cook IA. Reply to "Transcutaneous electric currents to target the peripheral and central nervous system in children with attention deficit hyperactivity disorder". Clin Neurophysiol. 2019 Oct;130(10):2008-2009. doi: 10.1016/j.clinph.2019.07.012. Epub 2019 Jul 23. No abstract available.
- James McGough 2022. "Efficacy of Trigeminal Nerve Stimulation for ADHD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05374187.
Frequently Asked Questions
Is it feasible for me to participate in this research?
"This clinical study is searching for approximately 280 participants with a diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) between the ages of 7 and 12." - Anonymous Online Contributor
Are there any opportunities at this time to participate in the experiment?
"According to the online data hosted on clinicaltrials.gov, this medical study is currently enrolling participants. It was initially posted on August 1st 2022 and had its most recent update done two weeks later." - Anonymous Online Contributor
How many individuals are being recruited for this medical research?
"Affirmative. Clinicaltrials.gov's records suggest that this clinical trial is currently recruiting participants, with an initial post date of August 1st 2022 and the most recent edit on August 16th 2022. The project requires 280 individuals to be recruited from 2 sites." - Anonymous Online Contributor
Is this research protocol open to participants aged younger than fifty?
"This clinical trial is tailored specifically for children between the ages of 7 and 12. For individuals outside this age bracket, there are 108 trials available to those younger than 18 and 35 studies that accommodate people over 65 years old." - Anonymous Online Contributor