12 Month Open Extension of TNS for ADHD.

Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial

Official title:

12 Month Open Extension Study of TNS for ADHD .

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03888391
• Other study ID #: NIMH R34 MH101282
• 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

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Active TNS

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
James McGough	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 scores ranging from 0-30, and higher scores signifying more severe symptoms.	Change over baseline, Month 3, Month 6, Month 9, Month 12
Other	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
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, Month 3, Month 6, Month 9, Month 12
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, Month 3, Month 6, Month 9, Month 12
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, Month 3, Month 6, Month 9, Month 12
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, Month 3, Month 6, Month 9, Month 12
Other	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
Other	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
Other	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
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, Month 3, Month 6, Month 9, Month 12
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, Month 3, Month 6, Month 9, Month 12
Secondary	Height	A dimensional measure assessed in cm.	Change over baseline, Month 3, Month 6, Month 9, Month 12
Secondary	Weight	A dimensional measure assessed in kg.	Change over baseline, Month 3, Month 6, Month 9, Month 12
Secondary	Systolic Blood Pressure	A dimensional measure assessed in mm Hg.	Change over baseline, Month 3, Month 6, Month 9, Month 12
Secondary	Diastolic Blood Pressure	A dimensional measure assessed in mm Hg.	Change over baseline, Month 3, Month 6, Month 9, Month 12
Secondary	Pulse	A dimensional measure assessed in heart beats per minute.	Change over baseline, Month 3, Month 6, Month 9, Month 12