Trials / Recruiting
RecruitingNCT07214545
External Trigeminal Nerve Stimulation for Children With ASD + ADHD to Reduce Elevated Symptoms
Phase IIa Clinical Trial of External Trigeminal Nerve Stimulation for Autistic Children With Attention Deficit/Hyperactivity Disorder
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- University of California, San Francisco · Academic / Other
- Sex
- All
- Age
- 7 Years – 14 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this clinical trial is to learn if external trigeminal nerve stimulation (eTNS) works to treat ADHD symptoms in children on the autism spectrum (ASD). It will also learn about the efficacy and tolerability of the eTNS device. The main questions it aims to answer are: * Does eTNS reduce ADHD symptoms? * Does eTNS improve core and associated features of ASD? Participation spans 8-12 weeks and includes: * 4-5 in-person visits * 4 brief virtual check-ins * Nightly use of the eTNS device with a small sticky patch applied to child's forehead * Randomized assignment (those who start with the sham device may try the active device later)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Trigeminal Nerve Stimulation | This intervention is expected to have an effect following a treatment period of 6 weeks. |
| DEVICE | Sham Trigeminal Nerve Stimulation | This intervention is NOT expected to have an effect following a treatment period of 6 weeks. |
Timeline
- Start date
- 2025-10-06
- Primary completion
- 2027-09-01
- Completion
- 2028-01-31
- First posted
- 2025-10-09
- Last updated
- 2025-10-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07214545. Inclusion in this directory is not an endorsement.