280 Participants Needed

eTNS for ADHD

Recruiting at 1 trial location
AD
MS
Overseen ByMark Stein, Ph.D.
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Los Angeles
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called TNS, which sends a small electrical signal to the forehead during sleep, in children aged 7-12 with ADHD. The signal helps activate brain areas that improve attention and impulse control.

Will I have to stop taking my current medications?

Yes, participants must stop taking any current medications that affect the central nervous system (CNS). If they were on psychostimulant medication, they need to be off it for one week or 5 half-lives of the medication.

Is eTNS safe for humans?

Research shows that eTNS is generally safe and well-tolerated in humans, with studies focusing on epilepsy indicating no significant issues with heart rate or blood pressure.12345

How is the eTNS treatment for ADHD different from other treatments?

The eTNS treatment for ADHD is unique because it is a non-invasive therapy that uses adhesive skin electrodes to stimulate the trigeminal nerve, unlike traditional medications that are taken orally. This method is similar to its use in epilepsy, where it has shown potential benefits without the need for drugs.12356

What data supports the effectiveness of the treatment eTNS for ADHD?

Research shows that trigeminal nerve stimulation (TNS) may help with ADHD, as a study found potential benefits in an open trial. Additionally, eTNS has been effective in reducing seizures in epilepsy, suggesting it might have positive effects on brain function.12567

Who Is on the Research Team?

SK

Sandra K. Loo, Ph.D.

Principal Investigator

University of California, Los Angeles

JJ

James J. McGough, M.D.

Principal Investigator

University of California, Los Angeles

MA

Mark A. Stein, Ph.D.

Principal Investigator

Seattle Children's Hospital

Are You a Good Fit for This Trial?

This trial is for children aged 7-12 with ADHD, as confirmed by specific diagnostic interviews. They must have a certain level of ADHD symptoms and be able to complete English language assessments and EEG tests. Kids should have an IQ of 80 or above and not be on CNS-affecting meds (though stable supplements are okay). Children with a history of psychosis, mania, seizures, severe head injury, autism spectrum disorder or major depression cannot participate.

Inclusion Criteria

Estimated Full Scale IQ >= 80 based on WASI subtests
CGI-S score at baseline >= 4
I can stay still and cooperate during an EEG test.
See 5 more

Exclusion Criteria

I have been diagnosed with autism or major depression.
Baseline suicidality
History of lifetime psychosis, mania, or seizure disorder
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

4-week double-blind, controlled trial of active vs. sham TNS. Participants use TNS nightly during sleep.

4 weeks
Weekly behavioral ratings and EEG assessments

Treatment Phase 2

Participants initially randomized to sham receive active TNS for an additional 4 weeks, with continued weekly assessments.

4 weeks
Weekly assessments

Follow-up

Brief naturalistic follow-ups via phone or Zoom at months 3 and 6 post-treatment.

6 months
2 visits (virtual)

Open-label extension (optional)

Positive responders to active eTNS are invited to participate in a 12-month open-label continuation phase.

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • eTNS
Trial Overview The study is testing external trigeminal nerve stimulation (eTNS) against a sham (fake) treatment to see if it helps reduce ADHD symptoms in kids over four weeks. It also looks at how brain connectivity and activation might influence the effectiveness of eTNS therapy.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active eTNSExperimental Treatment1 Intervention
Group II: Sham eTNSPlacebo Group2 Interventions

eTNS is already approved in United States for the following indications:

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Approved in United States as Monarch eTNS System for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials
1,594
Recruited
10,430,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Published Research Related to This Trial

Trigeminal nerve stimulation (TNS) was found to be effective in reducing ADHD symptoms in a blinded sham-controlled trial involving 62 children, showing a significant improvement in ADHD Rating Scales and Clinical Global Impression scores after 4 weeks of treatment.
TNS was well tolerated with no clinically meaningful adverse events reported, indicating it is a safe, minimal-risk option for managing ADHD, with effects comparable to non-stimulant medications.
Double-Blind, Sham-Controlled, Pilot Study of Trigeminal Nerve Stimulation for Attention-Deficit/Hyperactivity Disorder.McGough, JJ., Sturm, A., Cowen, J., et al.[2023]
External trigeminal nerve stimulation (ETNS) significantly reduced seizure frequency in patients with focal drug-resistant epilepsy (DRE), with a 50% response rate compared to 0% in the control group after 12 months.
ETNS was well-tolerated with no relevant adverse events, and it improved quality of life without affecting mood or cognitive function, indicating its potential as a safe long-term treatment option.
External trigeminal nerve stimulation for drug resistant epilepsy: A randomized controlled trial.Gil-Lรณpez, F., Boget, T., Manzanares, I., et al.[2021]
Trigeminal nerve stimulation (TNS) showed significant improvements in ADHD symptoms and executive functioning in a study of 24 youth participants aged 7-14 over an 8-week period, indicating its potential as a treatment option.
The therapy was found to be feasible and safe, with no significant risks reported, and it positively affected cognitive tasks related to response inhibition, suggesting further research is warranted to explore its efficacy.
An eight-week, open-trial, pilot feasibility study of trigeminal nerve stimulation in youth with attention-deficit/hyperactivity disorder.McGough, JJ., Loo, SK., Sturm, A., et al.[2019]

Citations

Double-Blind, Sham-Controlled, Pilot Study of Trigeminal Nerve Stimulation for Attention-Deficit/Hyperactivity Disorder. [2023]
External trigeminal nerve stimulation for drug resistant epilepsy: A randomized controlled trial. [2021]
An eight-week, open-trial, pilot feasibility study of trigeminal nerve stimulation in youth with attention-deficit/hyperactivity disorder. [2019]
An audit of external trigeminal nerve stimulation (eTNS) in epilepsy. [2018]
A prospective long-term study of external trigeminal nerve stimulation for drug-resistant epilepsy. [2018]
Acute and long-term safety of external trigeminal nerve stimulation for drug-resistant epilepsy. [2011]
The impact of external trigeminal nerve stimulator (e-TNS) on prevention and acute treatment of episodic and chronic migraine: A systematic review. [2023]
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