Trigeminal Nerve Stimulation for ADHD (TNS for ADHD)
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|ClinicalTrials.gov Identifier: NCT02155608|
Recruitment Status : Active, not recruiting
First Posted : June 4, 2014
Last Update Posted : November 13, 2017
The purpose of this study is to develop external Trigeminal Nerve Stimulation (eTNS) as a potential nonmedication treatment for attention-deficit/hyperactivity disorder (ADHD).
Study hypothesis address potential differences over 4 weeks of active vs. sham eTNS treatment on ADHD symptoms, measures of executive function, electroencephalography (EEG) profiles, other dimensional measures of height, weight, mood, anxiety, and sleep, and side effect profiles.
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder (ADHD)||Device: Active TNS Device: Sham TNS||Not Applicable|
This three-year developmental study is a double-blind randomized trial of active vs. inactive sham eTNS for ADHD, with four weeks acute treatment followed by an additional four weeks of clinical observation and testing after treatment cessation.
The study will enroll 85-90 participants aged 8-12 years to achieve a completion target of N=36 for each study condition (total final N = 72). Participants will meet Diagnostic and Statistical Manual-5 (DSM-5) criteria for ADHD, any current presentation, as established by the Behavior Disorders Module of the Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS-PL) and clinical interview.
Other screening procedures include measures of ADHD symptom severity, other behavioral ratings, and cognitive assessments. Once inclusion/exclusion criteria have been reviewed and verified, participants will have a pre-treatment visit to establish behavioral and cognitive baseline ratings and to obtain an EEG. Participants and parents will be instructed in the use of eTNS, and participants will begin use of the eTNS as directed during sleep each night. Participants will be randomized 1:1 to active or inactive sham eTNS. Participants, families, and most of the study team will remain blind to treatment assignment. Participants will have weekly assessments over the eight week study to assess behavioral, cognitive, and brain activation change and to monitor safety, tolerability, and compliance. Weekly ratings will be obtained from a parent, teacher, and clinician investigator. EEG will occur at baseline, end of treatment (week 4).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Developmental Pilot Study of External Trigeminal Nerve Stimulation for ADHD|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||May 30, 2018|
|Estimated Study Completion Date :||May 30, 2018|
Experimental: Active TNS
Device: Active TNS
Participants will receive active trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for 4 weeks.
Sham Comparator: Sham TNS
Device: Sham TNS
Participants will receive sham trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for 4 weeks.
- ADHD-IV Rating Scale (ADHD-RS) [ Time Frame: Week 4 ]A standard, frequently used, clinician completed measure of Diagnostic and Statistical Manual-IV (DSM-IV) ADHD symptoms
- Height [ Time Frame: Week 4 ]A physical finding
- Weight [ Time Frame: Week 4 ]A physical finding
- Blood pressure [ Time Frame: Week 4 ]A physical finding
- Pulse [ Time Frame: Week 4 ]A physical finding
- Children's Sleep Habits Questionnaire (CSHQ) [ Time Frame: Week 4 ]A parent completed scale to assess sleep related problems.
- Multidimensional Anxiety Scale for Children (MASC) [ Time Frame: Week 4 ]A parent completed rating of child anxiety.
- Children's Depression Inventory (CDI) [ Time Frame: Week 4 ]A child completed measure of depressive symptoms.
- Affective Reactivity Index (ARI) [ Time Frame: Week 4 ]A parent and child completed measure of irritability.
- Affective Posner Task [ Time Frame: Week 4 ]A laboratory measure of frustration tolerance.
- Side Effects Rating Scale [ Time Frame: Week 4 ]A structured measure of potential side effects.
- Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Week 4 ]A standard instrument to assess potential suicidality.
- Attention Network Task (ANT) Response Inhibition [ Time Frame: Week 4 ]A computer-administered laboratory measure of executive function.
- Spatial Working Memory (SWM) [ Time Frame: Week 4 ]A computer-administered laboratory measure of executive function.
- Behavior Rating Inventory of Executive Functioning (BRIEF) [ Time Frame: Week 4 ]A parent completed rating of child executive function.
- Electroencephalography (EEG) Cortical Activation [ Time Frame: Week 4 ]A laboratory measure of cortical activity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02155608
|United States, California|
|UCLA Semel Institute|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||James J McGough, M.D.||University of California, Los Angeles|
|Principal Investigator:||Sandra K Loo, Ph.D.||University of California, Los Angeles|