What side effects are associated with this type of intervention?

Common treatments for ADHD include medications like stimulants (e.g., methylphenidate, amphetamines) and non-stimulants (e.g., atomoxetine, guanfacine). Side effects of these medications can include insomnia, decreased appetite, weight loss, increased heart rate, and potential for increased blood pressure. Neuromodulation treatments like External Trigeminal Nerve Stimulation (TNS) are generally considered minimal risk, with potential side effects including mild skin irritation at the site of application. Other neuromodulation techniques, such as transcranial magnetic stimulation (TMS), may cause mild headaches, scalp discomfort, or, rarely, seizures in susceptible individuals.

What prior FDA approvals exist?

The FDA has approved several neuromodulation treatments for ADHD, including external trigeminal nerve stimulation (TNS). TNS is a non-invasive treatment that has shown promise in reducing ADHD symptoms in children. Other neuromodulation techniques, such as transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), have been studied for ADHD, but they are not yet widely approved for this indication. Traditional pharmacological treatments for ADHD include stimulants like methylphenidate and non-stimulants like atomoxetine and guanfacine, which have been FDA-approved for managing ADHD symptoms.

What other types of research exist?

Promising, novel alternatives to External Trigeminal Nerve Stimulation (TNS) for ADHD treatment in 2024 include Transcranial Magnetic Stimulation (TMS) and Transcranial Direct-Current Stimulation (tDCS). Both methods have shown efficacy in treating neuropsychiatric conditions and may offer benefits for ADHD patients.

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Neuromodulation

eTNS for ADHD

N/A

Recruiting

Led By Sandra K. Loo, Ph.D.

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to cooperate during EEG

Male and female children ages 7 to 12 years with DSM-5 ADHD, any current presentation, as determined by diagnostic interview, Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS), and clinical interview

Must not have

Current diagnosis of autism spectrum disorder or major depression

History of seizure disorder or head injury with loss of consciousness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 1, 2, 3, 4, 5, 6, 7, 8, 16, 20

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since eTNS is non-invasive and considered minimal risk, side effects are expected to be very mild but may include discomfort at the site of stimulation or skin irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can stay still and cooperate during an EEG test.

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My child is between 7 to 12 years old and has been diagnosed with ADHD.

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Both my child and I can complete forms in English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with autism or major depression.

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I have had seizures or a head injury that made me lose consciousness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 1, 2, 3, 4, 5, 6, 7, 8, 16, 20

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 1, 2, 3, 4, 5, 6, 7, 8, 16, 20

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1, 2, 3, 4, 5, 6, 7, 8, 16, 20 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in ADHD Rating Scale-5 (ADHD-RS-5)

Secondary study objectives

Mental Depression

Change in Conners Short Form - Parent

Change in Conners Short Form - Teacher

+6 more

Other study objectives

Change in Attention Network Task - Go/NoGo

Change in Behavior Rating Inventory of Executive Functioning (BRIEF)

Change in Children's Sleep Habits Questionnaire (CSHQ)

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active eTNSExperimental Treatment1 Intervention

Following screening and determination of eligibility , participants at baseline are randomized to receive 4 weeks nightly treatment with active eTNS. Positive responders will be invited to participate in a 12-month open-label continuation phase.

Group II: Sham eTNSPlacebo Group2 Interventions

Following screening and determination of eligibility, participants at baseline are randomize to receive 4 weeks nightly treatment with sham eTNS. At conclusion of the double-blind phase, participants randomized to sham will be provided an opportunity to receive an additional 4 weeks nightly treatment with active eTNS. Positive responders to active eTNS will be invited to participate in a 12-month open-label continuation phase.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Active eTNS

2015

N/A

~70

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for ADHD include stimulant medications such as methylphenidate and amphetamines, which work by increasing the levels of dopamine and norepinephrine in the brain, thereby improving attention and reducing hyperactive and impulsive behaviors. Non-stimulant medications like atomoxetine also target norepinephrine but through different mechanisms. Neuromodulation techniques, such as Transcranial Magnetic Stimulation (TMS) and External Trigeminal Nerve Stimulation (TNS), aim to modulate brain activity through electrical or magnetic stimulation. These treatments are important for ADHD patients as they offer alternative or adjunctive options to traditional medications, potentially reducing symptoms with fewer side effects. TNS, specifically, is a non-invasive method that may improve ADHD symptoms by enhancing fronto-parietal connectivity, which is crucial for attention regulation.

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