12 Month Open Extension of TNS for ADHD.

12 Month Open Extension Study of TNS for ADHD .

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
• Intervention / Treatment: Device: Active TNS

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Semel Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active TNS; 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.	Device: Active TNS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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, Month 3, Month 6, Month 9, Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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, Month 3, Month 6, Month 9, Month 12
Height	A dimensional measure assessed in cm.	Change over baseline, Month 3, Month 6, Month 9, Month 12
Weight	A dimensional measure assessed in kg.	Change over baseline, Month 3, Month 6, Month 9, Month 12
Systolic Blood Pressure	A dimensional measure assessed in mm Hg.	Change over baseline, Month 3, Month 6, Month 9, Month 12
Diastolic Blood Pressure	A dimensional measure assessed in mm Hg.	Change over baseline, Month 3, Month 6, Month 9, Month 12
Pulse	A dimensional measure assessed in heart beats per minute.	Change over baseline, Month 3, Month 6, Month 9, Month 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conners Global Index - Parent Report	Parent completed dimensional rating of ADHD symptoms, with scores ranging from 0-30, and higher scores signifying more severe symptoms.	Change over baseline, Month 3, Month 6, Month 9, Month 12
Conner 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, Month 3, Month 6, Month 9, Month 12
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, Month 3, Month 6, Month 9, Month 12
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, Month 3, Month 6, Month 9, Month 12
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, Month 3, Month 6, Month 9, Month 12
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, Month 3, Month 6, Month 9, Month 12
Multidimensional Anxiety Scale for Children (MASC) Parent Report	A parent completed measure of child anxiety, with scores ranging fro 0-300, and higher scores indicating greater severity.	Change over baseline, Month 3, Month 6, Month 9, Month 12
Children's Depression Rating Scale - Revised (CDRS-R)	A clinician completed dimensional measure of child 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 define remission.	Change over baseline, Month 3, Month 6, Month 9, Month 12
Behavior Rating Inventory of Executive Functioning (BRIEF)	A parent completed rating of executive functioning. Comprises 5 sub scales that measure various measures of behavior and cognition. Raw scores for each measure are converted to T scores ranging from 28 to 103, with higher scores indicating greater difficulties.	Change over baseline, Month 3, Month 6, Month 9, Month 12

Collaborators and Investigators

• Sponsor: James McGough
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: James J. McGough, M.D., University of California, Los Angelesr

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): May 30, 2018
• Study Completion (Actual): May 30, 2018

Study Registration Dates

• First Submitted: March 20, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (Actual): March 25, 2019

Study Record Updates

• Last Update Posted (Actual): May 29, 2019
• Last Update Submitted That Met QC Criteria: May 17, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: ADHD; neuromodulation; trigeminal nerve stimulation
• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: NIMH R34 MH101282; R34MH101282 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes