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Completed

NCT Number: NCT03870737

Four-week Open-trial Extension TNS for ADHD

The purpose of this study will be to offer children previously randomized to sham treatment in a 5-week double-blind sham controlled study of Trigeminal Nerve Stimulation for ADHD (NCT02155608) an opportunity to receive 4-weeks active TNS treatment.

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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 study will enroll participants with ADHD who previously participated in a 5-week sham-controlled investigation of Trigeminal Nerve Stimulation as a treatment for ADHD, and who were randomized to the sham condition.

In the double-blind trial (NCT02155608), children ages 8-12 years undergo study screening and if eligible begin 4 weeks nightly treatment with active or sham TNS administered nightly during sleep. At the conclusion of the 4-week trial, all interventions (both active and sham TNS) are discontinued with blinding remaining in place for an additional week to assess possible residual treatment effects. Participants' randomized condition is unblinded at Week 5.

All participants randomized to sham in the double-blind trial are invited to participate in a 4-week open-trial of TNS to allow all participants the opportunity to benefit from the active intervention.

During this 4-week open-extension trial, interested participants will receive nightly active TNS during sleep. The final study visit (Visit 5) of the double-blind study will serve as baseline for this open-extension. Participants will return for clinic assessments at Weeks 2 and 4. Participants who achieve clinically significant improvement from active TNS over the 4-week open trial will be invited to receive a year of nightly active-TNS therapy as part of a 12-month extension study.

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 8-12 with DSM-5 ADHD, and current presentation, as determined by KSADS and clinical interview
  • participated in a previous randomized, double-blind, sham-controlled trial of TNS for ADHD, and randomized to the sham condition.
  • parents able and willing to monitor proper use of the TNS device and complete all required rating scales
  • parent and participants able to compete study rating scales and other measures in English

Exclusion criteria

  • currently requiring any medication with CNS effects

Treatment and study plan

Active TNS

Device

Participants will receive 4-weeks nightly treatment with active TNS. Positive responders will be invited to participate in 12-month open-extension study.

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

Primary outcomes

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

    Time frame: Change over Baseline, Week 2, Week 4.

    A dimensional rating of ADHD symptoms, with scores ranging from 0 to 54, with higher scores signifying worse severity.

Secondary outcomes

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

    Time frame: Change over Baseline, Week 2, Week 4

    Categorical measure indicating degree improved or not improved compared with global functioning at baseline in the preceding double-blind trial. The base CGI-I scale is a 7-point measure that requires the investigator to assess how much the condition has improved or worsened compared to baseline prior to initiation of treatment. Ratings are (1) very much improved; (2) much improved; (3) minimally improved; (4) no change; (5) minimally worse; (6) much worse; (7) very much worse. For purposes of analysis, the measure is dichotomized such that scores <= 2 signify "improved" and scores > 2 signify "not improved."

  2. Height

    Time frame: Change over Baseline, Week 2, Week 4

    A dimensional measure assessed in cm.

  3. Weight

    Time frame: Change over Baseline, Week 2, Week 4

    A dimensional measure assessed in kg.

  4. Systolic Blood Pressure

    Time frame: Change over Baseline, Week 2, Week 4

    A dimensional measure assessed in mm HG.

  5. Diastolic Blood Pressure

    Time frame: Change over Baseline, Week 2, Week 4

    A dimensional measure assessed in mm HG.

  6. Pulse

    Time frame: Change over Baseline, Week 2, Week 4

    A dimensional measure assessed in heart beats per minute.

Other outcomes

  1. Conners Global Index - Parent Report

    Time frame: Change over Baseline and weekly for 4-week trial

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

  2. Conners Global Index - Teacher Report

    Time frame: Change over Baseline and weekly for 4-week trial

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

  3. Affective Reactivity Index (ARI-C) Child

    Time frame: Change over Baseline, Week 4

    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-P) Parent

    Time frame: Change over Baseline, Week 4

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

  5. Children's Sleep Habits Questionnaire (CSHQ)

    Time frame: Change over Baseline and weekly for 4-week 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.

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

    Time frame: Change over Baseline and Week 4

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

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

    Time frame: Change over Baseline and Week 4

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

  8. Children's Depression Rating Scale - Revised (CDRS-R)

    Time frame: Change over Baseline and Week 4

    A clinician-completed dimensional measure of childhood mood symptoms obtained from parent and child interview, with range of scores from 17 to 113, and higher scores indicating more severe depression. A score >= 40 suggests depression; scores <= 28 defines remission.

  9. Behavior Rating Inventor of Executive Functioning (BRIEF)

    Time frame: Change over Baseline and weekly during 4-week trial

    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.

  10. Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: Baseline and weekly during 4-week trial

    standard instrument to assess potential suicidality with dichotomous scores (0 = absent; 1 = present) to rate various components of suicidal ideation and behavior. Data derived are summarized under Adverse Event Reporting.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Four-week Open-trial Extension Study of Trigeminal Nerve Stimulation (TNS) for Youth Previously Randomized to Sham in a Double-Blind Trial

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Mar 12, 2019
Registry last updated
May 29, 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.

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