Skip to main content
OpenTrials
Completed

NCT Number: NCT02155608

Trigeminal Nerve Stimulation for ADHD

The purpose of this study is to develop external Trigeminal Nerve Stimulation (eTNS) as a potential nonmedication treatment for attention-deficit/hyperactivity disorder (ADHD).

Study hypothesis address potential differences over 4 weeks of active vs. sham eTNS treatment on ADHD symptoms, measures of executive function, electroencephalography (EEG) profiles, other dimensional measures of height, weight, mood, anxiety, and sleep, and side effect profiles.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Attention Deficit Hyperactivity Disorder (ADHD) Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA Semel Institute

Los Angeles, California, 90095, United States

About this study

This three-year developmental study is a double-blind randomized trial of active vs. inactive sham eTNS for ADHD, with four weeks acute treatment followed by an additional one week of clinical observation and testing after treatment cessation.

The study will enroll 85-90 participants aged 8-12 years to achieve a completion target of N=36 for each study condition (total final N = 72). Participants will meet Diagnostic and Statistical Manual-5 (DSM-5) criteria for ADHD, any current presentation, as established by the Behavior Disorders Module of the Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS-PL) and clinical interview.

Other screening procedures include measures of ADHD symptom severity, other behavioral ratings, and cognitive assessments. Once inclusion/exclusion criteria have been reviewed and verified, participants in Phase 1A will have a pre-treatment visit to establish behavioral and cognitive baseline ratings and to obtain an EEG. Participants and parents will be instructed in the use of eTNS, and participants will begin use of the eTNS as directed during sleep each night. Participants will be randomized 1:1 to active or inactive sham eTNS. Participants, families, and most of the study team will remain blind to treatment assignment. Participants will have weekly assessments over the five-week study to assess behavioral, cognitive, and brain activation change and to monitor safety, tolerability, and compliance. Weekly ratings will be obtained from a parent, teacher, and clinician investigator. EEG will occur at baseline, end of treatment (week 4).

In Phase 1B, all participants remain blinded for one week after cessation of the intervention and return for a final visit to assess residual effects of eTNS therapy vs. sham.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • male and female children ages 8 to 12 years with DSM-5 ADHD, any current presentation, as determined by KSADS and clinical interview
  • minimum scores of 12 on both the inattentive and hyperactive/impulsive subscales of the baseline ADHD-RS
  • CGI-S score at baseline ≥ 4
  • no current medication with CNS effects
  • parents able and willing to monitor proper use of the stimulation device and complete all required rating scales
  • estimated Full Scale IQ ≥ 85 based on WASI subtests
  • parent and participant able to complete rating scales and other measures in English
  • able to cooperate during EEG

Exclusion criteria

  • impaired functioning to a degree that requires immediate initiation of ADHD medication in the opinion of the parents and/or investigator
  • current diagnosis of autism spectrum disorder or major depression
  • history of lifetime psychosis, mania, seizure disorder or head injury with loss of consciousness
  • baseline suicidality

Treatment and study plan

Active eTNS

Device

Participants will receive active trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for 4 weeks, followed by one week of observation and followup while remaining blinded following treatment discontinuation. Participant deemed to be positive responders to blinded active treatment will be invited to continue open eTNS in a 12 month extension period.

Other names: Trigeminal Nerve Stimulation, Monarch eTNS SystemTM (NeuroSigma, Inc., Los Angeles CA

Sham eTNS

Device

Participants will receive sham trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for 4 weeks, followed by one week of observation and followup while remaining blinded following treatment discontinuation. At the conclusion of the blinded trial, participants randomized to the sham group will be offered 4 weeks of open eTNS treatment. Participants deemed to be positive responders to open treatment will be invited to continue open nightly eTNS in a 12 month extension period.

Primary outcomes

  1. ADHD-IV Rating Scale (ADHD-RS)

    Time frame: Change over baseline and weeks 1, 2, 3, 4 and 5.

    A dimensional rating of ADHD symptoms, with scores ranging from 0 - 54, and higher scores indicating greater symptom severity.

Secondary outcomes

  1. Clinical Global Impression - Improvement (CGI-I)

    Time frame: Change over weeks 1, 2, 3, 4, and 5 compared with baseline.

    Categorical measure indicating degree improved or not improved compared with baseline for each treatment group. Minimum score = 1 (very much improved); Maximum score = 7 (very much worse). Results reflect number of participants stratified as "Improved" (CGI-I <=2) or "Not Improved" (CGI-I > 2).

  2. Conners Global Index - Parent Report

    Time frame: Change over baseline and weeks 1, 2, 3, 4, 5.

    Parent completed dimensional measure of ADHD symptoms, with score range from 0- 30, and higher scores indicating more severe symptoms.

  3. Affective Reactivity Index (ARI) - Child

    Time frame: Change over baseline and weeks 4 and 5.

    A child completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity.

  4. Affective Reactivity Index (ARI) - Parent Report

    Time frame: Change over baseline and weeks 4 and 5.

    A parent completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity.

  5. Multidimensional Anxiety Scale for Children (MASC) - Child Report

    Time frame: Change over baseline and weeks 4 and 5.

    A child completed rating of child anxiety, with scores ranging from 0-300, and higher scores indicating greater severity.

  6. Multidimensional Anxiety Scale for Children (MASC) - Parent Report

    Time frame: Change over baseline and weeks 4 and 5.

    A parent completed rating of child anxiety, with scores ranging from 0-300, and higher scores indicating greater severity.

  7. Height

    Time frame: Change over baseline and weeks 1, 4, and 5.

    A dimensional measure assessed in centimeters (cm).

  8. Weight

    Time frame: Change over baseline and weeks 1, 4, and 5.

    A dimensional measure assessed in kilograms (kg).

  9. Systolic Blood Pressure

    Time frame: Change over baseline and weeks 1, 4, and 5.

    A dimensional measure expressed in mm mercury (Hg).

  10. Diastolic Blood Pressure

    Time frame: Change over baseline and weeks 1, 4, and 5.

    A dimensional measure assessed in mm mercury (Hg).

  11. Pulse

    Time frame: Change over baseline and weeks weeks 1, 4, and 5.

    Heart rate in beats per minute (bpm).

  12. Children's Depression Inventory (CDI)

    Time frame: Change over baseline and weeks 4 and 5.

    A child completed self-report dimensional measure of depressive symptoms, with range of scores from 0 to 54. Higher scores reflect increasing depression. Cutoff scores < 17 to 20 are generally considered to be in the normative range. A score of 36 or higher reflects a relatively severe depression.

  13. Conners Global Index - Teacher

    Time frame: Change over baseline and weeks 1, 2, 3, 4, 5.

    Teacher completed dimensional measure of ADHD symptoms, with scores ranging from 0-30, and higher scores indicating more severe symptoms.

Other outcomes

  1. Affective Posner Task

    Time frame: Baseline, and Weeks 1 and 4

    A laboratory measure of frustration tolerance.

  2. Attention Network Task (ANT) Response Inhibition

    Time frame: Baseline, Weeks 1 and 4

    A computer-administered laboratory measure of executive function.

  3. Spatial Working Memory (SWM)

    Time frame: Baseline, Weeks 1 and 4

    A computer-administered laboratory measure of executive function.

  4. Electroencephalography (EEG)

    Time frame: Baseline and Week 4

    A laboratory measure of cortical activity.

  5. Behavior Rating Inventory of Executive Functioning (BRIEF)

    Time frame: Baseline, end of Weeks 4 and 5.

    A parent completed rating of child executive function. Comprises 5 sub scales that measure various measures of behavior and cognition. Raw scores on each measure are converted to T scores ranging from 28 to 103, with higher scores indicating greater difficulties.

  6. Children's Sleep Habits Questionnaire (CSHQ)

    Time frame: Weekly for double-blind trial.

    A parent completed 33-item scale to assess sleep related problems. Total scores range from 33 to 99 divided among 8 sub scales , with higher scores indicating more severe difficulties.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Developmental Pilot Study of External Trigeminal Nerve Stimulation for ADHD

Acronym: TNS for ADHD

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 4, 2014
Registry last updated
Jul 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.