12 Month Open Extension Study of TNS for ADHD .
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- ADHD-IV Rating Scale (ADHD-RS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 8 Years to 13 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 <=
- •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
- Not provided
Arms & Interventions
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.
Intervention: Active TNS (Device)
Outcomes
Primary Outcomes
ADHD-IV Rating Scale (ADHD-RS)
Time Frame: Change over baseline, Month 3, Month 6, Month 9, Month 12
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, 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)
- Pulse(Change over baseline, Month 3, Month 6, Month 9, Month 12)
Investigators
James McGough
Principal Investigator
University of California, Los Angeles