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Completed

NCT Number: NCT01388530

Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)

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.

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Key information

Conditions

Attention-Deficit/Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

7 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

UCLA

Los Angeles, California, 90095, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. ADHD-IV Rating Scale (ADHD-RS)

    Time frame: Baseline and Week 8.

    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.

Secondary outcomes

  1. Clinical Global Impression - Improvement (CGI-I)

    Time frame: Week 8

    A global measure of clinical improvement compared with baseline.

    A standard clinical trials rating scale with value from 1 (very much improved) to 7 (very much worse).

    Unit of measure - percentage improved based on CGI-I scores of 1 and 2 versus all others.

  2. Conners Global Index - Parent

    Time frame: Baseline and Week 8.

    A standard, parent completed measure of ADHD symptoms.

    Scale range from 0 (best) to 27 (worst).

    Unit of Measure - units on a scale.

    Outcome value reflects change from baseline at endpoint (Week 8).

  3. Attention Network Task - Incongruent Reaction Time

    Time frame: Baseline and Week 8.

    Laboratory measure of response inhibition. The measure assessed the reaction time in milliseconds (ms) using the Attention Network Task (ANT), which is a computerized test designed to evaluate the efficiency of an attention network.

    Outcome measure represents a change from Baseline at Week 8 for the ANT - Incongruent reaction time. Lower reaction time is consider a better outcome.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • NeuroSigma, Inc.

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 6, 2011
Registry last updated
Apr 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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