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

ConditionsAttention Deficit Disorder With Hyperactivity (ADHD)Autism Spectrum Disorder (ASD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-14
SponsorUniversity of California, San Francisco

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Trigeminal Nerve Stimulation

    Device

    This intervention is expected to have an effect following a treatment period of 6 weeks.

  • Sham Trigeminal Nerve Stimulation

    Device

    This intervention is NOT expected to have an effect following a treatment period of 6 weeks.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Active eTNS DeviceActive comparator 1 intervention
Group B: Sham eTNS DeviceSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in ADHD Symptoms

Examine the efficacy of external Trigeminal Nerve Stimulation (eTNS) in reducing ADHD symptoms as measured by the Attention-Deficit/Hyperactivity Disorder Rating Scale-5 (ADHD-RS-5; range 0-54), where higher scores indicate worse symptoms.

Time frame
Baseline to end of treatment at 6 weeks

Secondary outcomes

1

Change in Social Responsiveness

Examine changes in social communication and related behaviors as measured by the Social Responsiveness Scale, Second Edition, Short Form (SRS-2-SF; range 0-48), where higher scores indicate worse impairment.

Time frame
Baseline to end of treatment at 6 weeks
2

Change in Restricted and Repetitive Behaviors

Examine changes in restricted and repetitive behaviors as measured by the Repetitive Behavior Scale-Revised (RBS-R; range 0-129), where higher scores indicate more severe repetitive behaviors.

Time frame
Baseline to end of treatment at 6 weeks
3

Change in Sleep Quality

Examine changes in sleep quality as measured by the Children's Sleep Habits Questionnaire (CSHQ; range 33-99), where higher scores indicate poorer sleep quality.

Time frame
Baseline to end of treatment at 6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

Source ClinicalTrials.gov
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