Four-week Open-trial Extension TNS for ADHD

Not Applicable

Completed

• Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
• Interventions: Device: Active TNS

• Registration Number: NCT03870737
• Lead Sponsor: University of California, Los Angeles

Brief Summary

The purpose of this study will be to offer children previously randomized to sham treatment in a 5-week double-blind sham controlled study of Trigeminal Nerve Stimulation for ADHD (NCT02155608) an opportunity to receive 4-weeks active TNS treatment.

Detailed Description

This study will enroll participants with ADHD who previously participated in a 5-week sham-controlled investigation of Trigeminal Nerve Stimulation as a treatment for ADHD, and who were randomized to the sham condition.

In the double-blind trial (NCT02155608), children ages 8-12 years undergo study screening and if eligible begin 4 weeks nightly treatment with active or sham TNS administered nightly during sleep. At the conclusion of the 4-week trial, all interventions (both active and sham TNS) are discontinued with blinding remaining in place for an additional week to assess possible residual treatment effects. Participants' randomized condition is unblinded at Week 5.

All participants randomized to sham in the double-blind trial are invited to participate in a 4-week open-trial of TNS to allow all participants the opportunity to benefit from the active intervention.

During this 4-week open-extension trial, interested participants will receive nightly active TNS during sleep. The final study visit (Visit 5) of the double-blind study will serve as baseline for this open-extension. Participants will return for clinic assessments at Weeks 2 and 4. Participants who achieve clinically significant improvement from active TNS over the 4-week open trial will be invited to receive a year of nightly active-TNS therapy as part of a 12-month extension study.

Study Timeline

• Study Start: 2014-12-01
• Primary Completion: 2018-05-30
• Study Completion: 2018-05-30
• Study First Submitted: 2019-03-05
• Study First Submitted QC: 2019-03-08
• Study First Posted: 2019-03-12
• Results First Submitted: 2019-04-03
• Results First Submitted QC: 2019-04-03
• Results First Posted: 2019-04-26
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-17
• Last Update Posted: 2019-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• male and female children ages 8-12 with DSM-5 ADHD, and current presentation, as determined by KSADS and clinical interview
• participated in a previous randomized, double-blind, sham-controlled trial of TNS for ADHD, and randomized to the sham condition.
• 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

Read More

Exclusion Criteria

• currently requiring any medication with CNS effects

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active TNS	Active TNS	Participants who previously underwent screening and determination of eligibility in a double-blind sham-controlled trial of TNS for ADHD, and randomized to sham, will be offered upon unblinding at the end of the 5-week controlled trial to receive 4-weeks open treatment with the active TNS condition.

Primary Outcome Measures

Name	Time	Method
ADHD-IV Rating Scale (ADHD-RS)	Change over Baseline, Week 2, Week 4.	A dimensional rating of ADHD symptoms, with scores ranging from 0 to 54, with higher scores signifying worse severity.

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression - Improvement (CGI-I)	Change over Baseline, Week 2, Week 4	Categorical measure indicating degree improved or not improved compared with global functioning at baseline in the preceding double-blind trial. The base CGI-I scale is a 7-point measure that requires the investigator to assess how much the condition has improved or worsened compared to baseline prior to initiation of treatment. Ratings are (1) very much improved; (2) much improved; (3) minimally improved; (4) no change; (5) minimally worse; (6) much worse; (7) very much worse. For purposes of analysis, the measure is dichotomized such that scores \<= 2 signify "improved" and scores \> 2 signify "not improved."
Diastolic Blood Pressure	Change over Baseline, Week 2, Week 4	A dimensional measure assessed in mm HG.
Height	Change over Baseline, Week 2, Week 4	A dimensional measure assessed in cm.
Weight	Change over Baseline, Week 2, Week 4	A dimensional measure assessed in kg.
Systolic Blood Pressure	Change over Baseline, Week 2, Week 4	A dimensional measure assessed in mm HG.
Pulse	Change over Baseline, Week 2, Week 4	A dimensional measure assessed in heart beats per minute.

Trial Locations

Locations (1)

UCLA Semel Institute; 🇺🇸 Los Angeles, California, United States