Using trigeminal nerve stimulation to treat ADHD in children
Efficacy of External Trigeminal Nerve Stimulation for Treatment of ADHD
This study is testing if a new non-invasive treatment using trigeminal nerve stimulation can help children aged 7-12 with ADHD feel better and improve their focus.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 7 Years to 12 Years |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 2 sites (Los Angeles, California and 1 other locations) |
| Trial ID | NCT05374187 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy of external trigeminal nerve stimulation (TNS), a non-invasive neuromodulation treatment, for children aged 7-12 diagnosed with Attention-Deficit Hyperactivity Disorder (ADHD). The study involves a 4-week double-blind, controlled trial comparing active TNS to a sham treatment, with assessments of ADHD symptoms, cognitive profiles, and brain activity through EEG. Participants will be monitored weekly for behavioral changes, and those showing positive responses will have a 12-month follow-up. The trial aims to replicate previous findings on TNS's safety and efficacy in a larger cohort across multiple sites.
Who should consider this trial
Good fit: Ideal candidates are children aged 7 to 12 years with a diagnosis of ADHD as per DSM-5 criteria.
Not a fit: Patients requiring immediate ADHD medication due to impaired functioning may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, non-invasive option for managing ADHD symptoms in children.
How similar studies have performed: Previous studies have shown promising results for TNS in treating ADHD, but this trial aims to expand on those findings with a larger participant group.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. male and female children ages 7 to 12 years with DSM-5 ADHD, any current presentation, as determined by diagnostic interview, Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS), and clinical interview; 2. total score \>= 24 on baseline ADHD-RS; 3. CGI-S score at baseline \>= 4; 4. no current medication with CNS effects (Participants previously on psychostimulant medication will be required to be not optimally treated and off medication for one week or 5 half-lives for all other medications); stable use of supplements will be permitted; 5. parents able and willing to monitor proper use of the stimulation device and complete all required rating scales; 6. estimated Full Scale IQ \>= 80 based on WASI subtests; 7. parent and participant able to complete rating scales and other measures in English; 8. able to cooperate during EEG Exclusion Criteria: 1. impaired functioning to a degree that requires immediate initiation of ADHD medication in the opinion of the parents and/or investigator; 2. current diagnosis of autism spectrum disorder or major depression; 3. history of lifetime psychosis, mania, or seizure disorder; 4. baseline suicidality; 5. history of seizure disorder or head injury with loss of consciousness
Where this trial is running
Los Angeles, California and 1 other locations
- University of California, Los Angeles — Los Angeles, California, United States (Recruiting)
- Seattle Children's Hospital — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Sandra K. Loo, Ph.D. — University of California, Los Angeles
- Study coordinator: Andrea Dillon, Ph.D.
- Email: andreadillon@mednet.ucla.edu
- Phone: (310) 825-3757
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.