Trigeminal Nerve Stimulation for ADHD

NCT02155608 | Completed Results DMC

• 2 other identifiers: NIMH R34MH101282R34MH101282
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to develop external Trigeminal Nerve Stimulation (eTNS) as a potential nonmedication treatment for attention-deficit/hyperactivity disorder (ADHD). Study hypothesis address potential differences over 4 weeks of active vs. sham eTNS treatment on ADHD symptoms, measures of executive function, electroencephalography (EEG) profiles, other dimensional measures of height, weight, mood, anxiety, and sleep, and side effect profiles.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

ADHD; neuromodulation; trigeminal nerve stimulation; cognition

Outcome Measures

Primary Outcomes (1)

• ADHD-IV Rating Scale (ADHD-RS)

  A dimensional rating of ADHD symptoms, with scores ranging from 0 - 54, and higher scores indicating greater symptom severity.

  Change over baseline and weeks 1, 2, 3, 4 and 5.

Secondary Outcomes (13)

• Clinical Global Impression - Improvement (CGI-I)

  Change over weeks 1, 2, 3, 4, and 5 compared with baseline.

• Conners Global Index - Parent Report

  Change over baseline and weeks 1, 2, 3, 4, 5.

• Affective Reactivity Index (ARI) - Child

  Change over baseline and weeks 4 and 5.

• Affective Reactivity Index (ARI) - Parent Report

  Change over baseline and weeks 4 and 5.

• Multidimensional Anxiety Scale for Children (MASC) - Child Report

  Change over baseline and weeks 4 and 5.

Other Outcomes (6)

• Affective Posner Task

  Baseline, and Weeks 1 and 4

• Attention Network Task (ANT) Response Inhibition

  Baseline, Weeks 1 and 4

• Spatial Working Memory (SWM)

  Baseline, Weeks 1 and 4

Study Arms (2)

Active eTNS

EXPERIMENTAL

Following screening and determination of eligibility, participants at baseline are randomized to receive 4 weeks nightly treatment with active or sham eTNS, followed by one week ongoing blinded assessment following treatment discontinuation. Positive responders will be invited to participate in a 12-month open extension.

Device: Active eTNS

Sham eTNS

SHAM COMPARATOR

Following screening and determination of eligibility, participants at baseline are randomized to receive 4 weeks nightly treatment with active or sham eTNS, followed by one week ongoing blinded assessment following treatment discontinuation. Following double-blind phase, interested participants randomized to sham have an option for a 4-week open TNS trial. Positive responders will be invited to participate in a 12-month open extension.

Device: Sham eTNS

Interventions

Active eTNS DEVICE

Participants will receive active trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for 4 weeks, followed by one week of observation and followup while remaining blinded following treatment discontinuation. Participant deemed to be positive responders to blinded active treatment will be invited to continue open eTNS in a 12 month extension period.

Also known as: Trigeminal Nerve Stimulation, Monarch eTNS SystemTM (NeuroSigma, Inc., Los Angeles CA

Active eTNS

Sham eTNS DEVICE

Participants will receive sham trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for 4 weeks, followed by one week of observation and followup while remaining blinded following treatment discontinuation. At the conclusion of the blinded trial, participants randomized to the sham group will be offered 4 weeks of open eTNS treatment. Participants deemed to be positive responders to open treatment will be invited to continue open nightly eTNS in a 12 month extension period.

Sham eTNS

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• male and female children ages 8 to 12 years with DSM-5 ADHD, any current presentation, as determined by KSADS and clinical interview
• minimum scores of 12 on both the inattentive and hyperactive/impulsive subscales of the baseline ADHD-RS
• CGI-S score at baseline ≥ 4
• no current medication with CNS effects
• parents able and willing to monitor proper use of the stimulation device and complete all required rating scales
• estimated Full Scale IQ ≥ 85 based on WASI subtests
• parent and participant able to complete rating scales and other measures in English
• able to cooperate during EEG

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
• current diagnosis of autism spectrum disorder or major depression
• history of lifetime psychosis, mania, seizure disorder or head injury with loss of consciousness
• baseline suicidality

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

UCLA Semel Institute

Los Angeles, California, 90095, United States

Location

Related Publications (2)

• McGough JJ, Sturm A, Cowen J, Tung K, Salgari GC, Leuchter AF, Cook IA, Sugar CA, Loo SK. Double-Blind, Sham-Controlled, Pilot Study of Trigeminal Nerve Stimulation for Attention-Deficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry. 2019 Apr;58(4):403-411.e3. doi: 10.1016/j.jaac.2018.11.013. Epub 2019 Jan 28.

  PMID: 30768393 RESULT

• Loo SK, Salgari GC, Ellis A, Cowen J, Dillon A, McGough JJ. Trigeminal Nerve Stimulation for Attention-Deficit/Hyperactivity Disorder: Cognitive and Electroencephalographic Predictors of Treatment Response. J Am Acad Child Adolesc Psychiatry. 2021 Jul;60(7):856-864.e1. doi: 10.1016/j.jaac.2020.09.021. Epub 2020 Oct 15.

  PMID: 33068751 DERIVED

Related Links

• Pub Med Abstract

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Insufficient data were collected with the Conners Teacher Report leading to small number of participants analyzed. Results are likely not valid.

Results Point of Contact

• Title: James McGough, M.D.
• Organization: University of California, Los Angeles

jmcgough@mednet.ucla.edu

310-794-7841

Study Officials

• James J McGough, M.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Sandra K Loo, Ph.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind, sham-controlled.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Psychiatry

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 4, 2014
• Study Start: April 1, 2015
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2018
• Last Updated: July 2, 2019
• Results First Posted: April 12, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)