12 Month Open Extension of TNS for ADHD.

James McGough

Status: Completed

Conditions: Attention Deficit Hyperactivity Disorder (ADHD)

Treatments: Device: Active TNS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03888391

NIMH R34 MH101282

R34MH101282 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 8 to 13 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Active TNS

Experimental group

Description:

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.

Treatment:

Device: Active TNS