Skip to main content
OpenTrials
Completed

NCT Number: NCT03888391

12 Month Open Extension of TNS for ADHD.

Participants who exhibit sufficient ADHD symptom improvement in a prior study of active TNS will be invited to continue in a 12-month extension study, designed to collect additional data on long-term response and tolerability and to provide participants ongoing clinical benefit from treatment.

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–13 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

Children, ages 8-12 years, participated in a 5 week double-blind, sham-controlled study of active Trigeminal Nerve Stimulation (TNS). Participants randomized to sham in the double-blind, were then invited into a 4-week open TNS trial. Participants who met positive response criteria to active TNS, either during the original double-blind study or the open-treatment followup, were invited to continue their TNS treatment in a 12-month open extension phase.

Participants who continued in the 12-month extension returned for study visits every 3 months to assess ongoing response and safety/tolerability data. Unless otherwise noted, baseline line assessments in the 12-month extension are taken from the final visit of the preceding active treatment trial, i.e. the visit at which positive response criteria were met.

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 8-13 with DSM-5 ADHD, and current presentation, as determined by KSADS and clinical interview
  • received active TNS therapy in a previous trial and demonstrated a CGI-I score <= 2.
  • 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

  • none

Treatment and study plan

Active TNS

Device

Primary outcomes

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

    Time frame: Change over baseline, Month 3, Month 6, Month 9, Month 12

    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, Month 3, Month 6, Month 9, Month 12

    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, Month 3, Month 6, Month 9, Month 12

    A dimensional measure assessed in cm.

  3. Weight

    Time frame: Change over baseline, Month 3, Month 6, Month 9, Month 12

    A dimensional measure assessed in kg.

  4. Systolic Blood Pressure

    Time frame: Change over baseline, Month 3, Month 6, Month 9, Month 12

    A dimensional measure assessed in mm Hg.

  5. Diastolic Blood Pressure

    Time frame: Change over baseline, Month 3, Month 6, Month 9, Month 12

    A dimensional measure assessed in mm Hg.

  6. Pulse

    Time frame: Change over baseline, Month 3, Month 6, Month 9, Month 12

    A dimensional measure assessed in heart beats per minute.

Other outcomes

  1. Conners Global Index - Parent Report

    Time frame: Change over baseline, Month 3, Month 6, Month 9, Month 12

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

  2. Conner Global Index - Teacher Report

    Time frame: Change over baseline, Month 3, Month 6, Month 9, Month 12

    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, Month 3, Month 6, Month 9, Month 12

    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, Month 3, Month 6, Month 9, Month 12

    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, Month 3, Month 6, Month 9, Month 12

    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, Month 3, Month 6, Month 9, Month 12

    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, Month 3, Month 6, Month 9, Month 12

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

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

    Time frame: Change over baseline, Month 3, Month 6, Month 9, Month 12

    A clinician completed dimensional measure of child 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 define remission.

  9. Behavior Rating Inventory of Executive Functioning (BRIEF)

    Time frame: Change over baseline, Month 3, Month 6, Month 9, Month 12

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

Sponsors and collaborators

Lead sponsor

James McGough

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

12 Month Open Extension Study of TNS for ADHD .

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Mar 25, 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.

Related clinical trials

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