Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)

Inclusion Criteria:

- male and female youth age 9 to 14 years with Diagnostic and Statistical Manuel -IV
(DSM-IV) ADHD, combined subtype as determined by Kiddie Schedule for Affective
Disorders and Schizophrenia (KSADS) and clinical interview

- minimum scores of 12 on both the inattentive and hyperactive/impulsive subscales of
the baseline ADHD-Rating Scale (ADHD-RS)S

- Clinical Global Impression- Severity (CGI-S) score at baseline

- no current medications with central nervous system (CNS) affects

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

Exclusion Criteria:

- impaired functioning to a degree that requires immediate initiation of ADHD
medication in the opinion of the parents and/or investigator; 2) current diagnosis of
pervasive developmental disorder or major depression.

- history of lifetime psychosis or mania

- current suicidality

- history of seizure disorder, tic disorder, or head injury with loss of consciousness.