12 Month Open Extension of TNS for ADHD.

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.

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.

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.

A dimensional rating of ADHD symptoms, with scores ranging from 0 to 54, with higher scores signifying worse severity.

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."

Parent completed dimensional rating of ADHD symptoms, with scores ranging from 0-30, and higher scores signifying more severe symptoms.

Teacher completed dimensional rating of ADHD symptoms, with scores ranging from 0-30, and higher scores indicating more severe symptoms.

A child completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity.

A parent completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity.

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.

A child completed rating of child anxiety, with scores ranging from 0-300, and higher scores indicating greater severity.

A parent completed measure of child anxiety, with scores ranging fro 0-300, and higher scores indicating greater severity.

A clinician completed dimensional measure of child 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 define remission.

A parent completed rating of executive functioning. Comprises 5 sub scales that measure various measures of behavior and cognition. Raw scores for each measure are converted to T scores ranging from 28 to 103, with higher scores indicating greater difficulties.

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