NCT03888391

12 Month Open Extension of TNS for ADHD.

12 Month Open Extension Study of TNS for ADHD .

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: James McGough · Academic / Other
• Sex: All
• Age: 8 Years – 13 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Attention Deficit Hyperactivity Disorder (ADHD)

Interventions

Type	Name	Description
DEVICE	Active TNS

Timeline

• Start date: 2014-12-01
• Primary completion: 2018-05-30
• Completion: 2018-05-30
• First posted: 2019-03-25
• Last updated: 2019-05-29
• Results posted: 2019-04-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study