Trigeminal Nerve Stimulation for ADHD

This three-year developmental study is a double-blind randomized trial of active vs.
inactive sham eTNS for ADHD, with four weeks acute treatment followed by an additional four
weeks of clinical observation and testing after treatment cessation.

The study will enroll 85-90 participants aged 8-12 years to achieve a completion target of
N=36 for each study condition (total final N = 72). Participants will meet Diagnostic and
Statistical Manual-5 (DSM-5) criteria for ADHD, any current presentation, as established by
the Behavior Disorders Module of the Kiddie Schedule for Affective Disorders and
Schizophrenia (KSADS-PL) and clinical interview.

Other screening procedures include measures of ADHD symptom severity, other behavioral
ratings, and cognitive assessments. Once inclusion/exclusion criteria have been reviewed and
verified, participants will have a pre-treatment visit to establish behavioral and cognitive
baseline ratings and to obtain an EEG. Participants and parents will be instructed in the
use of eTNS, and participants will begin use of the eTNS as directed during sleep each
night. Participants will be randomized 1:1 to active or inactive sham eTNS. Participants,
families, and most of the study team will remain blind to treatment assignment. Participants
will have weekly assessments over the eight week study to assess behavioral, cognitive, and
brain activation change and to monitor safety, tolerability, and compliance. Weekly ratings
will be obtained from a parent, teacher, and clinician investigator. EEG will occur at
baseline, end of treatment (week 4).

Inclusion Criteria:

- male and female children ages 8 to 12 years with DSM-5 ADHD, any current
presentation, as determined by KSADS and clinical interview

- minimum scores of 12 on both the inattentive and hyperactive/impulsive subscales of
the baseline ADHD-RS

- CGI-S score at baseline ≥ 4

- no current medication with CNS effects

- parents able and willing to monitor proper use of the stimulation device and complete
all required rating scales

- estimated Full Scale IQ ≥ 80 based on WASI subtests

- parent and participant able to complete rating scales and other measures in English

- able to cooperate during EEG

Exclusion Criteria:

- impaired functioning to a degree that requires immediate initiation of ADHD
medication in the opinion of the parents and/or investigator

- current diagnosis of autism spectrum disorder or major depression

- history of lifetime psychosis, mania, seizure disorder or head injury with loss of
consciousness

- baseline suicidality