12 Month Open Extension of TNS for ADHD.

NCT03888391 | Completed Results FDA Device

• 2 other identifiers: NIMH R34 MH101282R34MH101282
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Participants who exhibit sufficient ADHD symptom improvement in a prior study of active TNS will be invited to continue in a 12-month extension study, designed to collect additional data on long-term response and tolerability and to provide participants ongoing clinical benefit from treatment.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

ADHD; neuromodulation; trigeminal 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, Month 3, Month 6, Month 9, Month 12

Secondary Outcomes (6)

• Clinical Global Impression - Improvement (CGI-I)

  Change over baseline, Month 3, Month 6, Month 9, Month 12

• Height

  Change over baseline, Month 3, Month 6, Month 9, Month 12

• Weight

  Change over baseline, Month 3, Month 6, Month 9, Month 12

• Systolic Blood Pressure

  Change over baseline, Month 3, Month 6, Month 9, Month 12

• Diastolic Blood Pressure

  Change over baseline, Month 3, Month 6, Month 9, Month 12

Other Outcomes (9)

• Conners Global Index - Parent Report

  Change over baseline, Month 3, Month 6, Month 9, Month 12

• Conner Global Index - Teacher Report

  Change over baseline, Month 3, Month 6, Month 9, Month 12

• Affective Reactivity Index (ARI-C) Child

  Change over baseline, Month 3, Month 6, Month 9, Month 12

Study Arms (1)

Active TNS

EXPERIMENTAL

Participants will receive trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for up to 12 months of this open-extension trial.

Device: Active TNS

Interventions

Active TNS DEVICE

Active TNS

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• male and female children ages 8-13 with DSM-5 ADHD, and current presentation, as determined by KSADS and clinical interview
• received active TNS therapy in a previous trial and demonstrated a CGI-I score \<= 2.
• 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:

• none

Sponsors & Collaborators

• James McGough: lead
• National Institute of Mental Health (NIMH): collaborator

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 Disorders; Neurodevelopmental Disorders; Mental Disorders

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 Angelesr

  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: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Open-label active treatment

Study Record Dates

• First Submitted: March 20, 2019
• First Posted: March 25, 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 29, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)