Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: Trigeminal Nerve Stimulation for Attention Deficit Disorder With Hyperactivity (ADHD)

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 how well it works and tolerability of the eTNS device.

Official registry: https://clinicaltrials.gov/study/NCT07214545 · University of California, San Francisco · enrollment listed as 60

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Trigeminal Nerve Stimulation, or Sham Trigeminal Nerve Stimulation. The registry lists allocation as randomized. 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).

They plan to enroll about 60 people at San Francisco. Taking part typically means using or being fitted with a device plus check-ins.

Official title (unrewritten)

Phase IIa Clinical Trial of External Trigeminal Nerve Stimulation for Autistic Children With Attention Deficit/Hyperactivity Disorder

Interventions: Trigeminal Nerve Stimulation, Sham Trigeminal Nerve Stimulation

Primary outcome (registry wording): Change in ADHD Symptoms

Who it is for (from inclusion criteria)

  • Ages 7 Years to 14 Years
  • 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 Diagnostic Interview-Revised (ADI-R)
  • 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

Contact

No central phone on the registry card. Use the official listing to reach a site.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT07214545 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07214545?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07214545?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary