Four-week Open-trial Extension TNS for ADHD

Four-week Open-trial Extension Study of Trigeminal Nerve Stimulation (TNS) for Youth Previously Randomized to Sham in a Double-Blind Trial

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
• Intervention / Treatment: Device: Active TNS

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Semel Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADHD-IV Rating Scale (ADHD-RS)	A dimensional rating of ADHD symptoms, with scores ranging from 0 to 54, with higher scores signifying worse severity.	Change over Baseline, Week 2, Week 4.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Global Impression - Improvement (CGI-I)	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."	Change over Baseline, Week 2, Week 4
Height	A dimensional measure assessed in cm.	Change over Baseline, Week 2, Week 4
Weight	A dimensional measure assessed in kg.	Change over Baseline, Week 2, Week 4
Systolic Blood Pressure	A dimensional measure assessed in mm HG.	Change over Baseline, Week 2, Week 4
Diastolic Blood Pressure	A dimensional measure assessed in mm HG.	Change over Baseline, Week 2, Week 4
Pulse	A dimensional measure assessed in heart beats per minute.	Change over Baseline, Week 2, Week 4

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conners Global Index - Parent Report	Parent completed dimensional rating of ADHD symptoms,with score range from 0- 30, and higher scores indicating more severe symptoms.	Change over Baseline and weekly for 4-week trial
Conners Global Index - Teacher Report	Teacher completed dimensional rating of ADHD symptoms,with scores ranging from 0-30, and higher scores indicating more severe symptoms.	Change over Baseline and weekly for 4-week trial
Affective Reactivity Index (ARI-C) Child	A child-completed dimensional measure of emotional reactivity,with scores ranging from 0-12, and higher scores indicating greater severity.	Change over Baseline, Week 4
Affective Reactivity Index (ARI-P) Parent	A parent-completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity.	Change over Baseline, Week 4
Children's Sleep Habits Questionnaire (CSHQ)	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.	Change over Baseline and weekly for 4-week trial
Multidimensional Anxiety Scale for Children (MASC) - Child Report	A child-completed rating of child anxiety, with scores ranging from 0-300, and higher scores indicating greater severity.	Change over Baseline and Week 4
Multidimensional Anxiety Scale for Children (MASC) - Parent Report	A parent-completed rating of child anxiety, with scores ranging from 0-300, and higher scores indicating greater severity.	Change over Baseline and Week 4
Children's Depression Rating Scale - Revised (CDRS-R)	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.	Change over Baseline and Week 4
Behavior Rating Inventor of Executive Functioning (BRIEF)	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.	Change over Baseline and weekly during 4-week trial
Columbia-Suicide Severity Rating Scale (C-SSRS)	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.	Baseline and weekly during 4-week trial

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: National Institute of Mental Health (NIMH)

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): May 30, 2018
• Study Completion (Actual): May 30, 2018

Study Registration Dates

• First Submitted: March 5, 2019
• First Submitted That Met QC Criteria: March 8, 2019
• First Posted (Actual): March 12, 2019

Study Record Updates

• Last Update Posted (Actual): May 29, 2019
• Last Update Submitted That Met QC Criteria: May 17, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: ADHD; neuromodulation; trigeminal nerve stimulation
• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: NIH R34MH101282; R34MH101282 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No