Four-week Open-trial Extension Study of Trigeminal Nerve Stimulation (TNS) for Youth Previously Randomized to Sham in a Double-Blind Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 22
- Locations
- 2
- Primary Endpoint
- ADHD-IV Rating Scale (ADHD-RS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 8 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Active TNS (Device)
Outcomes
Primary Outcomes
ADHD-IV Rating Scale (ADHD-RS)
Time Frame: Change over Baseline, Week 2, Week 4.
A dimensional rating of ADHD symptoms, with scores ranging from 0 to 54, with higher scores signifying worse severity.
Secondary Outcomes
- Clinical Global Impression - Improvement (CGI-I)(Change over Baseline, Week 2, Week 4)
- Diastolic Blood Pressure(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)
- Pulse(Change over Baseline, Week 2, Week 4)
Investigators
James McGough
Principal Investigator
University of California, Los Angeles