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Trigeminal Nerve Stimulation for ADHD (TNS for ADHD)

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ClinicalTrials.gov Identifier: NCT02155608
Recruitment Status : Completed
First Posted : June 4, 2014
Results First Posted : April 12, 2019
Last Update Posted : July 2, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
James McGough, University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE June 2, 2014
First Posted Date  ICMJE June 4, 2014
Results First Submitted Date  ICMJE February 26, 2019
Results First Posted Date  ICMJE April 12, 2019
Last Update Posted Date July 2, 2019
Actual Study Start Date  ICMJE April 1, 2015
Actual Primary Completion Date May 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 2, 2014)
ADHD-IV Rating Scale (ADHD-RS) [ Time Frame: Week 4 ]
A standard, frequently used, clinican completed mesure of Diagnostic and Statistical Manual-IV (DSM-IV) ADHD symptoms
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2019)
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Height [ Time Frame: Change over baseline and weeks 1, 4, and 5. ]
    A dimensional measure assessed in centimeters (cm).
  • Weight [ Time Frame: Change over baseline and weeks 1, 4, and 5. ]
    A dimensional measure assessed in kilograms (kg).
  • Systolic Blood Pressure [ Time Frame: Change over baseline and weeks 1, 4, and 5. ]
    A dimensional measure expressed in mm mercury (Hg).
  • Diastolic Blood Pressure [ Time Frame: Change over baseline and weeks 1, 4, and 5. ]
    A dimensional measure assessed in mm mercury (Hg).
  • Pulse [ Time Frame: Change over baseline and weeks weeks 1, 4, and 5. ]
    Heart rate in beats per minute (bpm).
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2014)
  • Height [ Time Frame: Week 4 ]
    A physical finding
  • Weight [ Time Frame: Week 4 ]
    A physical finding
  • Blood pressure [ Time Frame: Week 4 ]
    A physical finding
  • Pulse [ Time Frame: Week 4 ]
    A physical finding
  • Children's Sleep Habits Questionnaire (CSHQ) [ Time Frame: Week 4 ]
    A parent completed scale to assess sleep related problems.
  • Multidimensional Anxiety Scale for Children (MASC) [ Time Frame: Week ]
    A parent completed rating of child anxiety.
  • Children's Depression Inventory (CDI) [ Time Frame: Week 4 ]
    A child completed measure of depressive symptoms.
  • Affective Reactivity Index (ARI) [ Time Frame: Week 4 ]
    A parent and child completed measure of irritability.
  • Affective Posner Task [ Time Frame: Week 4 ]
    A laboratory measure of frustration tolerance.
  • Side Effects Rating Scale [ Time Frame: Week 4 ]
    A structured measure of potential side effects.
  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Week 4 ]
    A standard intrument to assess potential suicidality.
  • Attention Network Task (ANT) Response Inhibition [ Time Frame: Week 4 ]
    A computer-administered laboratory measure of executive function.
  • Spatial Working Memory (SWM) [ Time Frame: Week 4 ]
    A computer-administered laboratory measure of executive function.
  • Behavor Rating Inventory of Executive Functioning (BRIEF) [ Time Frame: Week 4 ]
    A parent completed rating of child executive function.
  • Electroencephalography (EEG) Cortical Activation [ Time Frame: Week 4 ]
    A laboratory measure of cortical activity.
Current Other Pre-specified Outcome Measures
 (submitted: June 10, 2019)
  • Affective Posner Task [ Time Frame: Baseline, and Weeks 1 and 4 ]
    A laboratory measure of frustration tolerance.
  • Attention Network Task (ANT) Response Inhibition [ Time Frame: Baseline, Weeks 1 and 4 ]
    A computer-administered laboratory measure of executive function.
  • Spatial Working Memory (SWM) [ Time Frame: Baseline, Weeks 1 and 4 ]
    A computer-administered laboratory measure of executive function.
  • Electroencephalography (EEG) [ Time Frame: Baseline and Week 4 ]
    A laboratory measure of cortical activity.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trigeminal Nerve Stimulation for ADHD
Official Title  ICMJE Developmental Pilot Study of External Trigeminal Nerve Stimulation for ADHD
Brief Summary

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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double-blind, sham-controlled.
Primary Purpose: Treatment
Condition  ICMJE Attention Deficit Hyperactivity Disorder (ADHD)
Intervention  ICMJE
  • Device: Active eTNS
    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
  • Device: Sham eTNS
    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.
Study Arms  ICMJE
  • Experimental: Active eTNS
    Following screening and determination of eligibility, participants at baseline are randomized to receive 4 weeks nightly treatment with active or sham eTNS, followed by one week ongoing blinded assessment following treatment discontinuation. Positive responders will be invited to participate in a 12-month open extension.
    Intervention: Device: Active eTNS
  • Sham Comparator: Sham eTNS
    Following screening and determination of eligibility, participants at baseline are randomized to receive 4 weeks nightly treatment with active or sham eTNS, followed by one week ongoing blinded assessment following treatment discontinuation. Following double-blind phase, interested participants randomized to sham have an option for a 4-week open TNS trial. Positive responders will be invited to participate in a 12-month open extension.
    Intervention: Device: Sham eTNS
Publications * McGough JJ, Sturm A, Cowen J, Tung K, Salgari GC, Leuchter AF, Cook IA, Sugar CA, Loo SK. Double-Blind, Sham-Controlled, Pilot Study of Trigeminal Nerve Stimulation for Attention-Deficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry. 2019 Apr;58(4):403-411.e3. doi: 10.1016/j.jaac.2018.11.013. Epub 2019 Jan 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2017)
62
Original Estimated Enrollment  ICMJE
 (submitted: June 2, 2014)
90
Actual Study Completion Date  ICMJE May 30, 2018
Actual Primary Completion Date May 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02155608
Other Study ID Numbers  ICMJE NIMH R34MH101282
R34MH101282 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party James McGough, University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: James J McGough, M.D. University of California, Los Angeles
Principal Investigator: Sandra K Loo, Ph.D. University of California, Los Angeles
PRS Account University of California, Los Angeles
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP