12 Month Open Extension of TNS for ADHD.

James McGough18 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Interventions

Active TNSDEVICE

Eligibility

Sex: ALLMin age: 8 YearsMax age: 13 Years

Medical Language ↔ Plain English

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

Locations (1)

UCLA Semel Institute

Los Angeles, California, United States

Outcomes

Primary Outcomes

ADHD-IV Rating Scale (ADHD-RS)

A dimensional rating of ADHD symptoms, with scores ranging from 0 to 54, with higher scores signifying worse severity.