Clinical trial NCT03870737: Four-week Open-trial Extension TNS for ADHD
Official title: Four-week Open-trial Extension Study of Trigeminal Nerve Stimulation (TNS) for Youth Previously Randomized to Sham in a Double-Blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Keywords: ADHD
neuromodulation
trigeminal nerve stimulation
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-03-12
Enrollment: 22
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Exclusion Criteria:

* currently requiring any medication with CNS effects

Primary outcomes:
measure: ADHD-IV Rating Scale (ADHD-RS)
timeFrame: Change over Baseline, Week 2, Week 4.
Secondary outcomes:
measure: Clinical Global Impression - Improvement (CGI-I)
timeFrame: Change over Baseline, Week 2, Week 4
measure: Height
timeFrame: Change over Baseline, Week 2, Week 4
measure: Weight
timeFrame: Change over Baseline, Week 2, Week 4
measure: Systolic Blood Pressure
timeFrame: Change over Baseline, Week 2, Week 4
measure: Diastolic Blood Pressure
timeFrame: Change over Baseline, Week 2, Week 4
measure: Pulse
timeFrame: Change over Baseline, Week 2, Week 4
Other outcomes:
measure: Conners Global Index - Parent Report
timeFrame: Change over Baseline and weekly for 4-week trial
measure: Conners Global Index - Teacher Report
timeFrame: Change over Baseline and weekly for 4-week trial
measure: Affective Reactivity Index (ARI-C) Child
timeFrame: Change over Baseline, Week 4
measure: Affective Reactivity Index (ARI-P) Parent
timeFrame: Change over Baseline, Week 4
measure: Children's Sleep Habits Questionnaire (CSHQ)
timeFrame: Change over Baseline and weekly for 4-week trial
measure: Multidimensional Anxiety Scale for Children (MASC) - Child Report
timeFrame: Change over Baseline and Week 4
measure: Multidimensional Anxiety Scale for Children (MASC) - Parent Report
timeFrame: Change over Baseline and Week 4
measure: Children's Depression Rating Scale - Revised (CDRS-R)
timeFrame: Change over Baseline and Week 4
measure: Behavior Rating Inventor of Executive Functioning (BRIEF)
timeFrame: Change over Baseline and weekly during 4-week trial
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline and weekly during 4-week trial
Locations:
city: Los Angeles
country: United States
facility: UCLA Semel Institute
state: California
Study officials:
affiliation: University of California, Los Angeles
name: James J. McGough, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Sandra K. Loo, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: