Attention Deficit Disorder With Hyperactivity (ADHD)eTNS CARESNCT07214545
External Trigeminal Nerve Stimulation for Children With ASD + ADHD to Reduce Elevated Symptoms
A study testing Trigeminal Nerve Stimulation in people with Attention Deficit Disorder With Hyperactivity (ADHD) and Autism Spectrum Disorder (ASD), run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity (ADHD), Autism Spectrum Disorder (ASD)
- What is being tested?
- Trigeminal Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2025to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCSF Nancy Friend Pritzker Psychiatry Building
San Francisco, California, 94107
Jazzy Benes, MS, 5108510856, jazzy.benes@ucsf.edu
James McCracken, MD
About this study
Official title: Phase IIa Clinical Trial of External Trigeminal Nerve Stimulation for Autistic Children With Attention Deficit/Hyperactivity Disorder
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)
- Being tested
- Trigeminal Nerve Stimulation, Sham Trigeminal Nerve Stimulation
- Keywords
- eTNS, external trigeminal nerve stimulation, eTNS CARES
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trigeminal Nerve StimulationDevice
This intervention is expected to have an effect following a treatment period of 6 weeks.
Sham Trigeminal Nerve StimulationDevice
This intervention is NOT expected to have an effect following a treatment period of 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active eTNS Device | Active comparator | Not described Receives: Device: Trigeminal Nerve Stimulation |
| Sham eTNS Device | Sham comparator | Not described Receives: Device: Sham Trigeminal Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to end of treatment at 6 weeks
Secondary outcomes (3)
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.
Measured: Baseline to end of treatment at 6 weeks
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.
Measured: Baseline to end of treatment at 6 weeks
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.
Measured: Baseline to end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start6 Oct 2025
- Primary completionSep 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With Hyperactivity (ADHD)Studies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James T McCracken, M.D., University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214545
- Sponsor's protocol ID
- 25-44041
- Acronym
- eTNS CARES
- Status last verified
- Oct 2026
- First submitted
- 11 Sep 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIa Clinical Trial of External Trigeminal Nerve Stimulation for Autistic Children With Attention Deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT07214545
- Acronym / sponsor ID
- eTNS CARES / 25-44041
- Keywords
- eTNS, external trigeminal nerve stimulation, eTNS CARES
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active eTNS Device | Active comparator | Device: Trigeminal Nerve Stimulation |
| Sham eTNS Device | Sham comparator | Device: Sham Trigeminal Nerve Stimulation |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trigeminal Nerve StimulationThis intervention is expected to have an effect following a treatment period of 6 weeks. | Device | Active eTNS Device |
| Sham Trigeminal Nerve StimulationThis intervention is NOT expected to have an effect following a treatment period of 6 weeks. | Device | Sham eTNS Device |
Primary outcome
Change in ADHD Symptoms
Time frame: Baseline to end of treatment at 6 weeks
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.
3 secondary outcomes
Change in Social Responsiveness
Time frame: Baseline to end of treatment at 6 weeks
Change in Restricted and Repetitive Behaviors
Time frame: Baseline to end of treatment at 6 weeks
Change in Sleep Quality
Time frame: Baseline to end of treatment at 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
UCSF Nancy Friend Pritzker Psychiatry Building
San Francisco, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trigeminal Nerve Stimulation in people with Attention Deficit Disorder With Hyperactivity (ADHD) and Autism Spectrum Disorder (ASD), run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ADHD Symptoms (time frame: Baseline to end of treatment at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.