Trigeminal Nerve Stimulation for ADHD in Children with Autism

(eTNS CARES Trial)

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must not be taking: Antipsychotics, Stimulants

Disqualifiers: Major depression, Psychosis, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a device called external trigeminal nerve stimulation (eTNS) can reduce ADHD symptoms in children with autism. The researchers will also examine if the device improves autism-related traits and assess how well children tolerate it. Participants will be randomly assigned to use either an active or sham device, with some starting with the sham and potentially trying the active device later. This trial suits children diagnosed with both autism and ADHD, who have an IQ over 70, and are stable on their current medications. As an unphased trial, this study offers a unique opportunity for participants to contribute to groundbreaking research that could lead to new treatment options.

Do I have to stop taking my current medications for the trial?

The trial requires that participants are stable on their current medications for at least 4 weeks before starting. However, if you are currently using antipsychotic or stimulant medications, you cannot participate in the trial.

What prior data suggests that the eTNS device is safe for children with ADHD and autism?

Research shows that external trigeminal nerve stimulation (eTNS) is generally easy for people to handle. The Monarch eTNS device, used in this treatment, has received FDA approval for treating ADHD in children, indicating its safety for this use.

In past studies, eTNS proved effective for ADHD, performing comparably to some non-stimulant medications. These studies did not identify any major safety issues, suggesting that eTNS is a low-risk option.

Overall, current evidence supports eTNS as a safe treatment, but it is important to remember that each child might react differently. Discuss any concerns with the healthcare team running the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike conventional treatments for ADHD, which often involve medications like stimulants or behavioral therapy, External Trigeminal Nerve Stimulation (eTNS) offers a non-invasive approach that targets the trigeminal nerve through mild electrical pulses. Researchers are excited about eTNS because it avoids the side effects commonly associated with medication, like sleep disturbances and appetite suppression. This treatment is especially promising for children with both ADHD and autism, as it provides a novel mechanism of action that might be gentler and more suitable for their needs.

What evidence suggests that this eTNS device is effective for treating ADHD symptoms in children with autism?

This trial will compare the effects of active external trigeminal nerve stimulation (eTNS) with a sham eTNS device in children with autism who have ADHD. Research has shown that eTNS might help reduce ADHD symptoms. In a previous study, participants demonstrated faster reaction times in attention tasks after 8 weeks of treatment. This treatment stimulates a nerve in the forehead, which may help manage ADHD symptoms. Another study found that most participants adhered to the treatment, and no serious side effects were reported. While more research is needed, these findings suggest that eTNS could be a promising option for managing ADHD symptoms in children with autism. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for children with both Autism Spectrum Disorder (ASD) and Attention-Deficit/Hyperactivity Disorder (ADHD). Participants will use the eTNS device nightly over 8-12 weeks, attend several in-person visits, and have virtual check-ins. Details on who can join or reasons for exclusion are not provided.

Inclusion Criteria

Ability to complete protocol testing

IQ > 70 as corroborated by prior testing (or obtained in study screening) with the Wechsler Abbreviated Scale of Intelligence Scale (WASI)

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.

Exclusion Criteria

History of moderate to severe coarse brain injury

Presence of implanted stimulator (e.g., vagal nerve stimulator)

Active dermatologic condition likely to interfere with eTNS electrode wearability

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the eTNS device nightly with a small sticky patch applied to the child's forehead. Randomized assignment with potential crossover from sham to active device.

6 weeks

4-5 visits (in-person), 4 brief virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• External Trigeminal Nerve Stimulation
• Sham Trigeminal Nerve Stimulation

Trial Overview The study tests if external trigeminal nerve stimulation (eTNS) reduces ADHD symptoms in kids with ASD. It involves a sham procedure to compare against the actual eTNS treatment. Kids are randomly chosen to start with either the real or sham device.

How Is the Trial Designed?

Group I: Active eTNS Device Active Control 1 Intervention

Group II: Sham eTNS Device Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07214545

Study Details | NCT07214545 | External Trigeminal Nerve ... The goal of this clinical trial is to learn if external trigeminal nerve stimulation (eTNS) works to treat ADHD symptoms in children on the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9714960/

Trigeminal Nerve Stimulation for Attention-Deficit/Hyperactivity ... In the open-label TNS study, a significant decrease in flanker task incongruent reaction time was reported after 8 weeks of treatment, whereas secondary ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2773021223000524

The use of external Trigeminal Nerve Stimulation as an ... The current hypothesis is that external trigeminal nerve stimulation (eTNS) may reduce ADHD symptoms by activating the trigeminal nerve located in the forehead, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05374187

Efficacy of Trigeminal Nerve Stimulation for ADHD This study is a large multisite randomized clinical trial to asses the efficacy of external trigeminal nerve stimulation (TNS), a novel, minimal risk, ...

5. researchgate.net researchgate.net/publication/393277974_The_efficacy_of_external_Trigeminal_Nerve_Stimulation_TNS_in_youth_with_Attention-DeficitHyperactivity_Disorder_ADHD_a_multi-centre_double-blind_randomized_sham-controlled_parallel-group_phase_IIb_tri

The efficacy of external Trigeminal Nerve Stimulation (TNS) ... Adherence was 94% and compliance 93%. Blinding was successful. No serious adverse events (SAEs) were reported, and side effects did not differ ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6481187/

Double-Blind, Sham-Controlled, Pilot Study of Trigeminal ... This study demonstrates TNS efficacy for ADHD in a blinded sham-controlled trial, with estimated treatment effect size similar to non-stimulants.

7. bcbsm.com bcbsm.com/amslibs/content/dam/public/mpr/mprsearch/pdf/2174289.pdf

MEDICAL POLICY - TRANSCUTANEOUS ELECTRICAL ... The external trigeminal nerve stimulation system is indicated “for treatment of pediatric attention deficit hyperactivity disorder as a ...