Four-week Open-trial Extension TNS for ADHD

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.

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