Four-week Open-trial Extension TNS for ADHD

Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial

Official title:

Four-week Open-trial Extension Study of Trigeminal Nerve Stimulation (TNS) for Youth Previously Randomized to Sham in a Double-Blind Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03870737
• Other study ID #: NIH R34MH101282
• Secondary ID: R34MH101282
• Status: Completed
• Phase: N/A
• Start date: December 1, 2014
• Est. completion date: May 30, 2018

Study information

• Verified date: May 2019
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder (ADHD)

Intervention

Device:
• Active TNS
Participants will receive 4-weeks nightly treatment with active TNS. Positive responders will be invited to participate in 12-month open-extension study.

Locations

Country	Name	City	State
United States	UCLA Semel Institute	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Conners Global Index - Parent Report	Parent completed dimensional rating of ADHD symptoms,with score range from 0- 30, and higher scores indicating more severe symptoms.	Change over Baseline and weekly for 4-week trial
Other	Conners Global Index - Teacher Report	Teacher completed dimensional rating of ADHD symptoms,with scores ranging from 0-30, and higher scores indicating more severe symptoms.	Change over Baseline and weekly for 4-week trial
Other	Affective Reactivity Index (ARI-C) Child	A child-completed dimensional measure of emotional reactivity,with scores ranging from 0-12, and higher scores indicating greater severity.	Change over Baseline, Week 4
Other	Affective Reactivity Index (ARI-P) Parent	A parent-completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity.	Change over Baseline, Week 4
Other	Children's Sleep Habits Questionnaire (CSHQ)	A parent-completed 33-item scale to assess sleep related problems. Total scores range from 33 to 99 divided among 8 sub scales , with higher scores indicating more severe difficulties.	Change over Baseline and weekly for 4-week trial
Other	Multidimensional Anxiety Scale for Children (MASC) - Child Report	A child-completed rating of child anxiety, with scores ranging from 0-300, and higher scores indicating greater severity.	Change over Baseline and Week 4
Other	Multidimensional Anxiety Scale for Children (MASC) - Parent Report	A parent-completed rating of child anxiety, with scores ranging from 0-300, and higher scores indicating greater severity.	Change over Baseline and Week 4
Other	Children's Depression Rating Scale - Revised (CDRS-R)	A clinician-completed dimensional measure of childhood mood symptoms obtained from parent and child interview, with range of scores from 17 to 113, and higher scores indicating more severe depression. A score >= 40 suggests depression; scores <= 28 defines remission.	Change over Baseline and Week 4
Other	Behavior Rating Inventor of Executive Functioning (BRIEF)	A parent completed rating of child executive function. Comprises 5 sub scales that measure various measures of behavior and cognition. Raw scores on each measure are converted to T scores ranging from 28 to 103, with higher scores indicating greater difficulties.	Change over Baseline and weekly during 4-week trial
Other	Columbia-Suicide Severity Rating Scale (C-SSRS)	standard instrument to assess potential suicidality with dichotomous scores (0 = absent; 1 = present) to rate various components of suicidal ideation and behavior. Data derived are summarized under Adverse Event Reporting.	Baseline and weekly during 4-week trial
Primary	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.	Change over Baseline, Week 2, Week 4.
Secondary	Clinical Global Impression - Improvement (CGI-I)	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."	Change over Baseline, Week 2, Week 4
Secondary	Height	A dimensional measure assessed in cm.	Change over Baseline, Week 2, Week 4
Secondary	Weight	A dimensional measure assessed in kg.	Change over Baseline, Week 2, Week 4
Secondary	Systolic Blood Pressure	A dimensional measure assessed in mm HG.	Change over Baseline, Week 2, Week 4
Secondary	Diastolic Blood Pressure	A dimensional measure assessed in mm HG.	Change over Baseline, Week 2, Week 4
Secondary	Pulse	A dimensional measure assessed in heart beats per minute.	Change over Baseline, Week 2, Week 4