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External Trigeminal Nerve Stimulation for Children With ASD + ADHD to Reduce Elevated Symptoms

NCT07214545 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-10-09

No results posted yet for this study

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

  • Attention Deficit Disorder With Hyperactivity (ADHD)
  • Autism Spectrum Disorder (ASD)

Interventions

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-06
Primary Completion
2027-09-30
Completion
2028-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07214545 on ClinicalTrials.gov