Four-week Open-trial Extension TNS for ADHD

NCT ID: NCT03870737

Last Updated: 2019-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-01
• Study Completion Date: 2018-05-30

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.

Detailed Description

This study will enroll participants with ADHD who previously participated in a 5-week sham-controlled investigation of Trigeminal Nerve Stimulation as a treatment for ADHD, and who were randomized to the sham condition.

In the double-blind trial (NCT02155608), children ages 8-12 years undergo study screening and if eligible begin 4 weeks nightly treatment with active or sham TNS administered nightly during sleep. At the conclusion of the 4-week trial, all interventions (both active and sham TNS) are discontinued with blinding remaining in place for an additional week to assess possible residual treatment effects. Participants' randomized condition is unblinded at Week 5.

All participants randomized to sham in the double-blind trial are invited to participate in a 4-week open-trial of TNS to allow all participants the opportunity to benefit from the active intervention.

During this 4-week open-extension trial, interested participants will receive nightly active TNS during sleep. The final study visit (Visit 5) of the double-blind study will serve as baseline for this open-extension. Participants will return for clinic assessments at Weeks 2 and 4. Participants who achieve clinically significant improvement from active TNS over the 4-week open trial will be invited to receive a year of nightly active-TNS therapy as part of a 12-month extension study.

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 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.

Group Type: EXPERIMENTAL

Active TNS

Intervention Type: DEVICE

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

Interventions

Active TNS

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

Intervention Type: DEVICE

Other Intervention Names

Trigeminal Nerve Stimulation; Monarch eTNS SystemTM (NeuroSigma, Inc., Los Angeles CA

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• currently requiring any medication with CNS effects

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

James McGough

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James J. McGough, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

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

NIH R34MH101282

Identifier Type: -

Identifier Source: org_study_id