RECRUITING

Efficacy of Trigeminal Nerve Stimulation for ADHD

Conditions

Attention-Deficit Hyperactivity Disorder ADHD Neuromodulation Trigeminal Nerve Stimulation Cognition EEG

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Efficacy of External Trigeminal Nerve Stimulation for Treatment of ADHD

Quick Facts

Study Start:2022-09-01

Study Completion:2026-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05374187

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.

Ages Eligible for Study:7 Years to 12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Andrea Dillon, Ph.D.

CONTACT

(310) 825-3757

andreadillon@mednet.ucla.edu

Principal Investigator

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 Locations (Sites)

University of California, Los Angeles

Los Angeles, California, 90095

United States

Seattle Children's Hospital

Seattle, Washington, 98105

United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-01

Study Completion Date2026-01-31

Study Record Updates

Study Start Date2022-09-01

Study Completion Date2026-01-31

Terms related to this study

Keywords Provided by Researchers

ADHD
Neuromodulation
Trigeminal Nerve Stimulation
Cognition
EEG

Additional Relevant MeSH Terms

Attention-Deficit Hyperactivity Disorder