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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 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

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor

1,530 Previous Clinical Trials

10,277,922 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

2,784 Previous Clinical Trials

2,688,995 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