Four-week Open-trial Extension TNS for ADHD

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Attention Deficit Hyperactivity Disorder (ADHD)

Intervention / Treatment
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* Device: Active TNS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active TNS<br>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<br>* Participants will receive 4-weeks nightly treatment with active TNS. Positive responders will be invited to participate in 12-month open-extension study.<br>* Other names: Monarch eTNS SystemTM (NeuroSigma, Inc., Los Angeles CA;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, neuromodulation, trigeminal nerve stimulation