12 Month Open Extension Study of TNS for ADHD .
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- ADHD-IV Rating Scale (ADHD-RS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Active TNS (Device)
结局指标
主要结局
ADHD-IV Rating Scale (ADHD-RS)
时间窗: 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.
次要结局
- 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)
研究者
James McGough
Principal Investigator
University of California, Los Angeles