12 Month Open Extension of TNS for ADHD.

Study Overview
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Brief Summary
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Participants who exhibit sufficient ADHD symptom improvement in a prior study of active TNS will be invited to continue in a 12-month extension study, designed to collect additional data on long-term response and tolerability and to provide participants ongoing clinical benefit from treatment.

Detailed Description
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Children, ages 8-12 years, participated in a 5 week double-blind, sham-controlled study of active Trigeminal Nerve Stimulation (TNS). Participants randomized to sham in the double-blind, were then invited into a 4-week open TNS trial. Participants who met positive response criteria to active TNS, either during the original double-blind study or the open-treatment followup, were invited to continue their TNS treatment in a 12-month open extension phase. Participants who continued in the 12-month extension returned for study visits every 3 months to assess ongoing response and safety/tolerability data. Unless otherwise noted, baseline line assessments in the 12-month extension are taken from the final visit of the preceding active treatment trial, i.e. the visit at which positive response criteria were met.

Official Title
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12 Month Open Extension Study of TNS for ADHD .

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 8-13 with DSM-5 ADHD, and current presentation, as determined by KSADS and clinical interview received active TNS therapy in a previous trial and demonstrated a CGI-I score <= 2. 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: none

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 13 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
Interventional Model Description: Open-label active treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active TNS<br>Participants will receive trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for up to 12 months of this open-extension trial. | Device: Active TNS<br> <br> |

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, Month 3, Month 6, Month 9, Month 12 | 

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, Month 3, Month 6, Month 9, Month 12 | 
| Height | A dimensional measure assessed in cm. | Change over baseline, Month 3, Month 6, Month 9, Month 12 | 
| Weight | A dimensional measure assessed in kg. | Change over baseline, Month 3, Month 6, Month 9, Month 12 | 
| Systolic Blood Pressure | A dimensional measure assessed in mm Hg. | Change over baseline, Month 3, Month 6, Month 9, Month 12 | 
| Diastolic Blood Pressure | A dimensional measure assessed in mm Hg. | Change over baseline, Month 3, Month 6, Month 9, Month 12 | 
| Pulse | A dimensional measure assessed in heart beats per minute. | Change over baseline, Month 3, Month 6, Month 9, Month 12 | 

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