Attention Deficit Disorder With Hyperactivity study: Trigeminal Nerve Stimulation
Official title External Trigeminal Nerve Stimulation for Children With ASD + ADHD to Reduce Elevated Symptoms
ClinicalTrials.gov ID: NCT07214545
What this study is testing
- What it's testing
- The study wants to find out if external trigeminal nerve stimulation can lower ADHD symptoms and improve autism-related features, and whether the device is safe and tolerable.
- Who it's for
- Children who have both autism spectrum disorder and attention‑deficit/hyperactivity disorder.
- What's involved
- Kids will wear a small sticky patch on their forehead each night that delivers gentle nerve stimulation, attend 4‑5 clinic visits, and have a few brief virtual check‑ins. Some will start with a fake (sham) device before switching to the real one.
- Time commitment
- The trial lasts about 8 to 12 weeks with several in‑person visits and occasional virtual check‑ins.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 to 14
You may be able to join if
- Confirmed clinician diagnosis of ASD according to DSM-5 criteria, corroborated by prior testing (or obtained in study screening) with the Autism...
- IQ \> 70 as corroborated by prior testing (or obtained in study screening) with the Wechsler Abbreviated Scale of Intelligence Scale (WASI)
- Confirmed diagnosis of ADHD according to DSM-5 criteria with minimum ADHD-RS score of \> 24
- Stable on current medications for a minimum of 4 weeks before baseline
- Ability to complete protocol testing
You likely can't join if
- Current major depression, history of psychosis, bipolar disorder, elevated risk of self-harm
- History of moderate to severe coarse brain injury
- Active medical illness expected to interfere with study assessments
- Presence of implanted stimulator (e.g., vagal nerve stimulator)
- Active dermatologic condition likely to interfere with eTNS electrode wearability
- Sleep disorder likely to interfere with nightly eTNS in the opinion of the study physician
See the full eligibility criteria
- Confirmed clinician diagnosis of ASD according to DSM-5 criteria, corroborated by prior testing (or obtained in study screening) with the Autism Diagnostic Observation Schedule (ADOS) with or without the Autism...
- IQ \> 70 as corroborated by prior testing (or obtained in study screening) with the Wechsler Abbreviated Scale of Intelligence Scale (WASI)
- Confirmed diagnosis of ADHD according to DSM-5 criteria with minimum ADHD-RS score of \> 24
- Stable on current medications for a minimum of 4 weeks before baseline
- Ability to complete protocol testing
- Both the child participant and their primary caregiver must be fluent in English (speaking, reading, and understanding), as the questionnaires and assessment tools used in this study have been validated only in English.
- Current major depression, history of psychosis, bipolar disorder, elevated risk of self-harm
- History of moderate to severe coarse brain injury
- Active medical illness expected to interfere with study assessments
- Presence of implanted stimulator (e.g., vagal nerve stimulator)
- Active dermatologic condition likely to interfere with eTNS electrode wearability
- Sleep disorder likely to interfere with nightly eTNS in the opinion of the study physician
- Inability to communicate discomfort or pain
- Current and anticipated continued use of antipsychotic or stimulant medication
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 7 years to 14 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.