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12 Month Open Extension of TNS for ADHD.

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ClinicalTrials.gov Identifier: NCT03888391
Recruitment Status : Completed
First Posted : March 25, 2019
Results First Posted : April 29, 2019
Last Update Posted : May 29, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
James McGough, University of California, Los Angeles

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder (ADHD) Device: Active TNS Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open-label active treatment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 12 Month Open Extension Study of TNS for ADHD .
Study Start Date : December 1, 2014
Actual Primary Completion Date : May 30, 2018
Actual Study Completion Date : May 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active TNS
Participants will receive trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for up to 12 months of this open-extension trial.
Device: Active TNS



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03888391


Locations
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United States, California
UCLA Semel Institute
Los Angeles, California, United States, 90095
Sponsors and Collaborators
James McGough
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: James J. McGough, M.D. University of California, Los Angelesr
Principal Investigator: Sandra K. Loo, Ph.D. University of California, Los Angeles
  Study Documents (Full-Text)

Documents provided by James McGough, University of California, Los Angeles:
Informed Consent Form  [PDF] April 28, 2015


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Responsible Party: James McGough, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03888391     History of Changes
Other Study ID Numbers: NIMH R34 MH101282
R34MH101282 ( U.S. NIH Grant/Contract )
First Posted: March 25, 2019    Key Record Dates
Results First Posted: April 29, 2019
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by James McGough, University of California, Los Angeles:
ADHD
neuromodulation
trigeminal nerve stimulation
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders