NCT03870737

Brief Summary

The purpose of this study will be to offer children previously randomized to sham treatment in a 5-week double-blind sham controlled study of Trigeminal Nerve Stimulation for ADHD (NCT02155608) an opportunity to receive 4-weeks active TNS treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
2 months until next milestone

Results Posted

Study results publicly available

April 26, 2019

Completed
Last Updated

May 29, 2019

Status Verified

May 1, 2019

Enrollment Period

3.5 years

First QC Date

March 5, 2019

Results QC Date

April 3, 2019

Last Update Submit

May 17, 2019

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

ADHDneuromodulationtrigeminal nerve stimulation

Outcome Measures

Primary Outcomes (1)

  • ADHD-IV Rating Scale (ADHD-RS)

    A dimensional rating of ADHD symptoms, with scores ranging from 0 to 54, with higher scores signifying worse severity.

    Change over Baseline, Week 2, Week 4.

Secondary Outcomes (6)

  • Clinical Global Impression - Improvement (CGI-I)

    Change over Baseline, Week 2, Week 4

  • Height

    Change over Baseline, Week 2, Week 4

  • Weight

    Change over Baseline, Week 2, Week 4

  • Systolic Blood Pressure

    Change over Baseline, Week 2, Week 4

  • Diastolic Blood Pressure

    Change over Baseline, Week 2, Week 4

  • +1 more secondary outcomes

Other Outcomes (10)

  • Conners Global Index - Parent Report

    Change over Baseline and weekly for 4-week trial

  • Conners Global Index - Teacher Report

    Change over Baseline and weekly for 4-week trial

  • Affective Reactivity Index (ARI-C) Child

    Change over Baseline, Week 4

  • +7 more other outcomes

Study Arms (1)

Active TNS

EXPERIMENTAL

Participants who previously underwent screening and determination of eligibility in a double-blind sham-controlled trial of TNS for ADHD, and randomized to sham, will be offered upon unblinding at the end of the 5-week controlled trial to receive 4-weeks open treatment with the active TNS condition.

Device: Active TNS

Interventions

Active TNSDEVICE

Participants will receive 4-weeks nightly treatment with active TNS. Positive responders will be invited to participate in 12-month open-extension study.

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

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • male and female children ages 8-12 with DSM-5 ADHD, and current presentation, as determined by KSADS and clinical interview
  • participated in a previous randomized, double-blind, sham-controlled trial of TNS for ADHD, and randomized to the sham condition.
  • parents able and willing to monitor proper use of the TNS device and complete all required rating scales
  • parent and participants able to compete study rating scales and other measures in English

You may not qualify if:

  • currently requiring any medication with CNS effects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Semel Institute

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Results Point of Contact

Title
James J. 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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 5, 2019

First Posted

March 12, 2019

Study Start

December 1, 2014

Primary Completion

May 30, 2018

Study Completion

May 30, 2018

Last Updated

May 29, 2019

Results First Posted

April 26, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)