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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 1, 2, 3, 4, 5, 6, 7, 8, 16, 20
Awards & highlights

Study Summary

This trial is testing a new, non-invasive treatment for ADHD in children. It is looking at whether the treatment works and whether it is better than a sham treatment. It is also looking at how the treatment affects the brain and whether there are predictors of who will respond to the treatment.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in ADHD Rating Scale-5 (ADHD-RS-5)
Secondary outcome measures
Mental Depression
Change in Conners Short Form - Parent
Change in Conners Short Form - Teacher
+6 more
Other outcome measures
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

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,528 Previous Clinical Trials
10,276,571 Total Patients Enrolled
10 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
836 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
National Institute of Mental Health (NIMH)NIH
2,782 Previous Clinical Trials
2,688,827 Total Patients Enrolled
94 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
19,765 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Sandra K. Loo, Ph.D.Principal InvestigatorUniversity of California, Los Angeles
2 Previous Clinical Trials
40 Total Patients Enrolled
2 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
40 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Media Library

Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial 2023: eTNS Highlights & Side Effects. Trial Name: NCT05374187 — N/A
eTNS (Neuromodulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05374187 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it feasible for me to participate in this research?

"This clinical study is searching for approximately 280 participants with a diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) between the ages of 7 and 12."

Answered by AI

Are there any opportunities at this time to participate in the experiment?

"According to the online data hosted on clinicaltrials.gov, this medical study is currently enrolling participants. It was initially posted on August 1st 2022 and had its most recent update done two weeks later."

Answered by AI

How many individuals are being recruited for this medical research?

"Affirmative. Clinicaltrials.gov's records suggest that this clinical trial is currently recruiting participants, with an initial post date of August 1st 2022 and the most recent edit on August 16th 2022. The project requires 280 individuals to be recruited from 2 sites."

Answered by AI

Is this research protocol open to participants aged younger than fifty?

"This clinical trial is tailored specifically for children between the ages of 7 and 12. For individuals outside this age bracket, there are 108 trials available to those younger than 18 and 35 studies that accommodate people over 65 years old."

Answered by AI

Who else is applying?

What site did they apply to?
University of California, Los Angeles
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

Compensation But learning about ways w condition.
PatientReceived no prior treatments
Recent research and studies
~147 spots leftby Jan 2026