12 Month Open Extension of TNS for ADHD.

NCT ID: NCT03888391

Last Updated: 2019-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-01
• Study Completion Date: 2018-05-30

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.

Detailed Description

Children, ages 8-12 years, participated in a 5 week double-blind, sham-controlled study of active Trigeminal Nerve Stimulation (TNS). Participants randomized to sham in the double-blind, were then invited into a 4-week open TNS trial. Participants who met positive response criteria to active TNS, either during the original double-blind study or the open-treatment followup, were invited to continue their TNS treatment in a 12-month open extension phase.

Participants who continued in the 12-month extension returned for study visits every 3 months to assess ongoing response and safety/tolerability data. Unless otherwise noted, baseline line assessments in the 12-month extension are taken from the final visit of the preceding active treatment trial, i.e. the visit at which positive response criteria were met.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active TNS

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.

Group Type: EXPERIMENTAL

Active TNS

Intervention Type: DEVICE

Interventions

Active TNS

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• none

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

James McGough

OTHER

Sponsor Role: lead

Responsible Party

James McGough

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

James J. McGough, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angelesr

Sandra K. Loo, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

UCLA Semel Institute

Los Angeles, California, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R34MH101282

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIMH R34 MH101282

Identifier Type: -

Identifier Source: org_study_id