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Trigeminal Nerve Stimulation for ADHD (TNS for ADHD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02155608
Recruitment Status : Active, not recruiting
First Posted : June 4, 2014
Last Update Posted : November 13, 2017
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 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.


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

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 four weeks 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 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 eight 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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Developmental Pilot Study of External Trigeminal Nerve Stimulation for ADHD
Study Start Date : December 2014
Estimated Primary Completion Date : May 30, 2018
Estimated Study Completion Date : May 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active TNS
Active TNS
Device: Active TNS
Participants will receive active trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for 4 weeks.
Other Names:
  • Trigeminal Nerve Stimulation
  • Monarch eTNS SystemTM (NeuroSigma, Inc., Los Angeles CA

Sham Comparator: Sham TNS
Sham TNS
Device: Sham TNS
Participants will receive sham trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for 4 weeks.




Primary Outcome Measures :
  1. ADHD-IV Rating Scale (ADHD-RS) [ Time Frame: Week 4 ]
    A standard, frequently used, clinician completed measure of Diagnostic and Statistical Manual-IV (DSM-IV) ADHD symptoms


Secondary Outcome Measures :
  1. Height [ Time Frame: Week 4 ]
    A physical finding

  2. Weight [ Time Frame: Week 4 ]
    A physical finding

  3. Blood pressure [ Time Frame: Week 4 ]
    A physical finding

  4. Pulse [ Time Frame: Week 4 ]
    A physical finding

  5. Children's Sleep Habits Questionnaire (CSHQ) [ Time Frame: Week 4 ]
    A parent completed scale to assess sleep related problems.

  6. Multidimensional Anxiety Scale for Children (MASC) [ Time Frame: Week 4 ]
    A parent completed rating of child anxiety.

  7. Children's Depression Inventory (CDI) [ Time Frame: Week 4 ]
    A child completed measure of depressive symptoms.

  8. Affective Reactivity Index (ARI) [ Time Frame: Week 4 ]
    A parent and child completed measure of irritability.

  9. Affective Posner Task [ Time Frame: Week 4 ]
    A laboratory measure of frustration tolerance.

  10. Side Effects Rating Scale [ Time Frame: Week 4 ]
    A structured measure of potential side effects.

  11. Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Week 4 ]
    A standard instrument to assess potential suicidality.

  12. Attention Network Task (ANT) Response Inhibition [ Time Frame: Week 4 ]
    A computer-administered laboratory measure of executive function.

  13. Spatial Working Memory (SWM) [ Time Frame: Week 4 ]
    A computer-administered laboratory measure of executive function.

  14. Behavior Rating Inventory of Executive Functioning (BRIEF) [ Time Frame: Week 4 ]
    A parent completed rating of child executive function.

  15. Electroencephalography (EEG) Cortical Activation [ Time Frame: Week 4 ]
    A laboratory measure of cortical activity.



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 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 ≥ 80 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

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): NCT02155608


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

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Responsible Party: James McGough, Professor of Clinical Psychiatry, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02155608     History of Changes
Other Study ID Numbers: NIMH R34MH101282
R34MH101282 ( U.S. NIH Grant/Contract )
First Posted: June 4, 2014    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017

Keywords provided by James McGough, University of California, Los Angeles:
ADHD
neuromodulation
trigeminal nerve stimulation
cognition

Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders