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Four-week Open-trial Extension TNS for ADHD

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ClinicalTrials.gov Identifier: NCT03870737
Recruitment Status : Completed
First Posted : March 12, 2019
Results First Posted : April 26, 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:
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.

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

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Four-week Open-trial Extension Study of Trigeminal Nerve Stimulation (TNS) for Youth Previously Randomized to Sham in a Double-Blind Trial
Actual 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 who previously underwent screening and determination of eligibility in a double-blind sham-controlled trial of TNS for ADHD, and randomized to sham, will be offered upon unblinding at the end of the 5-week controlled trial to receive 4-weeks open treatment with the active TNS condition.
Device: Active TNS
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 Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03870737


Locations
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United States, California
UCLA Semel Institute
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: James J. McGough, M.D. University of California, Los Angeles
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: NCT03870737     History of Changes
Other Study ID Numbers: NIH R34MH101282
R34MH101282 ( U.S. NIH Grant/Contract )
First Posted: March 12, 2019    Key Record Dates
Results First Posted: April 26, 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.: No
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