Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)

An Eight-Week, Open Trial Pilot Investigation of Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)

This proposal seeks to obtain preliminary data on the potential efficacy, tolerability, and feasibility of trigeminal nerve stimulation (TNS) as a treatment for Attention-Deficit/Hyperactivity Disorder (ADHD). If successful, this open-label, exploratory, pilot study will provide a basis for a federal grant application and larger controlled trials.

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.