Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)

NCT ID: NCT01388530

Last Updated: 2016-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2012-12-31

Brief Summary

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.

Conditions

Attention-Deficit/Hyperactivity Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

trigeminal nerve stimulation

Open label treatment with trigeminal nerve stimulation in an 8-week trial.

Group Type: EXPERIMENTAL

EMS 7500 Digital Muscle Stimulator

Intervention Type: DEVICE

A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep.

Interventions

EMS 7500 Digital Muscle Stimulator

A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NeuroSigma, Inc.

INDUSTRY

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

James McGough

Professor of Clinical Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James J McGough, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

UCLA

Los Angeles, California, United States

Countries

United States

Other Identifiers

UCLA-TNS/ADHD

Identifier Type: -

Identifier Source: org_study_id