Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)

NCT01388530 | Completed Early Phase 1 Results

• 1 other identifier: UCLA-TNS/ADHD
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• ADHD-IV Rating Scale (ADHD-RS)

  A standard, frequently used, clinician completed measure of Diagnostic and Statistical Manual -IV (DSM-IV) ADHD symptoms. Scale ranges from 0 (best) to 54 (worst). Unit of Measure - units on a scale. Outcome value reflects change from baseline at endpoint (Week 8) in ADHD-RS.

  Baseline and Week 8.

Secondary Outcomes (3)

• Clinical Global Impression - Improvement (CGI-I)

  Week 8

• Conners Global Index - Parent

  Baseline and Week 8.

• Attention Network Task - Incongruent Reaction Time

  Baseline and Week 8.

Study Arms (1)

trigeminal nerve stimulation

EXPERIMENTAL

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

Device: EMS 7500 Digital Muscle Stimulator

Interventions

EMS 7500 Digital Muscle Stimulator 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.

trigeminal nerve stimulation

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• NeuroSigma, Inc.: collaborator

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Limitations and Caveats

Early terminations were due to ambivalence about participation of social difficulties with compliance. No one left the study for adverse events or safety reasons. There were no clinically meaningful adverse events related to treatment.

Results Point of Contact

• Title: James McGough, M.D.
• Organization: David Geffen School of Medicine at UCLA

jmcgough@mednet.ucla.edu

310-794-7841

Study Officials

• James J McGough, M.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Psychiatry

Study Record Dates

• First Submitted: June 24, 2011
• First Posted: July 6, 2011
• Study Start: July 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 11, 2016
• Results First Posted: April 11, 2016

Record last verified: 2016-03

Locations

US (1)