Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)

University of California, Los Angeles (UCLA)

Status and phase

Completed

Early Phase 1

Conditions

Attention-Deficit/Hyperactivity Disorder

Treatments

Device: EMS 7500 Digital Muscle Stimulator

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01388530

UCLA-TNS/ADHD

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

7 to 14 years old

Volunteers

No Healthy Volunteers

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.