Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)

Attention-Deficit/Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01388530
• Other study ID #: UCLA-TNS/ADHD
• Status: Recruiting
• Phase: Phase 0
• First received: June 24, 2011
• Last updated: October 18, 2012
• Start date: July 2011
• Est. completion date: December 2012

Study information

• Verified date: October 2012
• Source: University of California, Los Angeles
• Contact: James J. McGough, M.D.
• Phone: 310-794-7841
• Email: jmcgough[@]mednet.ucla.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 14 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-Deficit/Hyperactivity Disorder
• Hyperkinesis

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	NeuroSigma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADHD-IV Rating Scale (ADHD-RS)	A standard, frequently used, clinician completed measure of DSM-IV ADHD symptoms.	Change from screening, baseline, week 4, and week 8 visits.	No
Secondary	Clinical Global Impression - Improvement (CGI-I)	A global measure of clinical improvement compared with baseline.	Weeks 1 through 8	No
Secondary	Conners Global Index - parent	A standard, parent completed measure of ADHD symptoms.	Change from baseline and weekly visits.	No
Secondary	Conners Global Index - teacher.	A standard teacher report form of ADHD symptoms.	Change from baseline, week 4, and week 8 visits.	No