Clinical trial NCT03888391: 12 Month Open Extension of TNS for ADHD.
Official title: 12 Month Open Extension Study of TNS for ADHD .
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: 2019-03-25
Enrollment: 18
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label active treatment
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: ADHD-IV Rating Scale (ADHD-RS)
timeFrame: Change over baseline, Month 3, Month 6, Month 9, Month 12
Secondary outcomes:
measure: Clinical Global Impression - Improvement (CGI-I)
timeFrame: Change over baseline, Month 3, Month 6, Month 9, Month 12
measure: Height
timeFrame: Change over baseline, Month 3, Month 6, Month 9, Month 12
measure: Weight
timeFrame: Change over baseline, Month 3, Month 6, Month 9, Month 12
measure: Systolic Blood Pressure
timeFrame: Change over baseline, Month 3, Month 6, Month 9, Month 12
measure: Diastolic Blood Pressure
timeFrame: Change over baseline, Month 3, Month 6, Month 9, Month 12
measure: Pulse
timeFrame: Change over baseline, Month 3, Month 6, Month 9, Month 12
Other outcomes:
measure: Conners Global Index - Parent Report
timeFrame: Change over baseline, Month 3, Month 6, Month 9, Month 12
measure: Conner Global Index - Teacher Report
timeFrame: Change over baseline, Month 3, Month 6, Month 9, Month 12
measure: Affective Reactivity Index (ARI-C) Child
timeFrame: Change over baseline, Month 3, Month 6, Month 9, Month 12
measure: Affective Reactivity Index (ARI-P) Parent
timeFrame: Change over baseline, Month 3, Month 6, Month 9, Month 12
measure: Children's Sleep Habits Questionnaire (CSHQ)
timeFrame: Change over baseline, Month 3, Month 6, Month 9, Month 12
measure: Multidimensional Anxiety Scale for Children (MASC) Child Report
timeFrame: Change over baseline, Month 3, Month 6, Month 9, Month 12
measure: Multidimensional Anxiety Scale for Children (MASC) Parent Report
timeFrame: Change over baseline, Month 3, Month 6, Month 9, Month 12
measure: Children's Depression Rating Scale - Revised (CDRS-R)
timeFrame: Change over baseline, Month 3, Month 6, Month 9, Month 12
measure: Behavior Rating Inventory of Executive Functioning (BRIEF)
timeFrame: Change over baseline, Month 3, Month 6, Month 9, Month 12
Locations:
city: Los Angeles
country: United States
facility: UCLA Semel Institute
state: California
Study officials:
affiliation: University of California, Los Angelesr
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: