Los Angeles, California 90095

  • Deficit/Hyperactivity Disorder

Purpose:

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.


Criteria:

Inclusion Criteria: - male and female youth age 9 to 14 years with 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-RS - 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.


NCT ID:

NCT01388530


Primary Contact:

James J. McGough, M.D.
Phone: 310-794-7841
Email: jmcgough@mednet.ucla.edu


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90095
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 02, 2021

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