Efficacy of Trigeminal Nerve Stimulation for ADHD

Description

This study is a large multisite randomized clinical trial to asses the efficacy of external trigeminal nerve stimulation (TNS), a novel, minimal risk, non-invasive neuromodulation treatment, for ADHD in children ages 7-12 years old (N=180). Study hypotheses address potential differences in ADHD symptoms over 4 weeks treatment with active vs. sham TNS in an expanded multi-site investigation; whether resting state fronto-parietal connectivity mediates TNS impact on ADHD symptoms; if changes in fronto-parietal activation, as measured by electroencephalography (EEG), predict TNS-related treatment outcomes; and whether a baseline cognitive profile similarly predicts response to TNS therapy.

Conditions

Attention-Deficit Hyperactivity Disorder

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Study Overview

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Study Details

Study overview

This study is a large multisite randomized clinical trial to asses the efficacy of external trigeminal nerve stimulation (TNS), a novel, minimal risk, non-invasive neuromodulation treatment, for ADHD in children ages 7-12 years old (N=180). Study hypotheses address potential differences in ADHD symptoms over 4 weeks treatment with active vs. sham TNS in an expanded multi-site investigation; whether resting state fronto-parietal connectivity mediates TNS impact on ADHD symptoms; if changes in fronto-parietal activation, as measured by electroencephalography (EEG), predict TNS-related treatment outcomes; and whether a baseline cognitive profile similarly predicts response to TNS therapy.

Efficacy of External Trigeminal Nerve Stimulation for Treatment of ADHD

Efficacy of Trigeminal Nerve Stimulation for ADHD

Condition
Attention-Deficit Hyperactivity Disorder
Intervention / Treatment

-

Contacts and Locations

Los Angeles

University of California, Los Angeles, Los Angeles, California, United States, 90095

Seattle

Seattle Children's Hospital, Seattle, Washington, United States, 98105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. 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;
  • 2. total score \>= 24 on baseline ADHD-RS;
  • 3. CGI-S score at baseline \>= 4;
  • 4. no current medication with CNS effects (Participants previously on psychostimulant medication will be required to be not optimally treated and off medication for one week or 5 half-lives for all other medications); stable use of supplements will be permitted;
  • 5. parents able and willing to monitor proper use of the stimulation device and complete all required rating scales;
  • 6. estimated Full Scale IQ \>= 80 based on WASI subtests;
  • 7. parent and participant able to complete rating scales and other measures in English;
  • 8. able to cooperate during EEG
  • 1. impaired functioning to a degree that requires immediate initiation of ADHD medication in the opinion of the parents and/or investigator;
  • 2. current diagnosis of autism spectrum disorder or major depression;
  • 3. history of lifetime psychosis, mania, or seizure disorder;
  • 4. baseline suicidality;
  • 5. history of seizure disorder or head injury with loss of consciousness

Ages Eligible for Study

7 Years to 12 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, Los Angeles,

Sandra K. Loo, Ph.D., PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

James J. McGough, M.D., PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Mark A. Stein, Ph.D., PRINCIPAL_INVESTIGATOR, Seattle Children's Hospital

Study Record Dates

2026-01-31