Trigeminal Nerve Stimulation for ADHD

Not Applicable

Completed

• Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
• Interventions: Device: Active eTNS; Device: Sham eTNS

• Registration Number: NCT02155608
• Lead Sponsor: University of California, Los Angeles

Brief Summary

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.

Detailed Description

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 one week 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 in Phase 1A 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 five-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).

In Phase 1B, all participants remain blinded for one week after cessation of the intervention and return for a final visit to assess residual effects of eTNS therapy vs. sham.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-06-02
• Study First Submitted QC: 2014-06-02
• Study First Posted: 2014-06-04
• Study Start: 2015-04-01
• Primary Completion: 2018-05-30
• Study Completion: 2018-05-30
• Results First Submitted: 2019-02-26
• Results First Submitted QC: 2019-03-21
• Results First Posted: 2019-04-12
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-26
• Last Update Posted: 2019-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• male and female children ages 8 to 12 years with DSM-5 ADHD, any current presentation, as determined by KSADS and clinical interview
• minimum scores of 12 on both the inattentive and hyperactive/impulsive subscales of the baseline ADHD-RS
• CGI-S score at baseline ≥ 4
• no current medication with CNS effects
• parents able and willing to monitor proper use of the stimulation device and complete all required rating scales
• estimated Full Scale IQ ≥ 85 based on WASI subtests
• parent and participant able to complete rating scales and other measures in English
• able to cooperate during EEG

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Exclusion Criteria

• impaired functioning to a degree that requires immediate initiation of ADHD medication in the opinion of the parents and/or investigator
• current diagnosis of autism spectrum disorder or major depression
• history of lifetime psychosis, mania, seizure disorder or head injury with loss of consciousness
• baseline suicidality

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active eTNS	Active eTNS	Following screening and determination of eligibility, participants at baseline are randomized to receive 4 weeks nightly treatment with active or sham eTNS, followed by one week ongoing blinded assessment following treatment discontinuation. Positive responders will be invited to participate in a 12-month open extension.
Sham eTNS	Sham eTNS	Following screening and determination of eligibility, participants at baseline are randomized to receive 4 weeks nightly treatment with active or sham eTNS, followed by one week ongoing blinded assessment following treatment discontinuation. Following double-blind phase, interested participants randomized to sham have an option for a 4-week open TNS trial. Positive responders will be invited to participate in a 12-month open extension.

Primary Outcome Measures

Name	Time	Method
ADHD-IV Rating Scale (ADHD-RS)	Change over baseline and weeks 1, 2, 3, 4 and 5.	A dimensional rating of ADHD symptoms, with scores ranging from 0 - 54, and higher scores indicating greater symptom severity.

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression - Improvement (CGI-I)	Change over weeks 1, 2, 3, 4, and 5 compared with baseline.	Categorical measure indicating degree improved or not improved compared with baseline for each treatment group. Minimum score = 1 (very much improved); Maximum score = 7 (very much worse). Results reflect number of participants stratified as "Improved" (CGI-I \<=2) or "Not Improved" (CGI-I \> 2).
Conners Global Index - Parent Report	Change over baseline and weeks 1, 2, 3, 4, 5.	Parent completed dimensional measure of ADHD symptoms, with score range from 0- 30, and higher scores indicating more severe symptoms.
Affective Reactivity Index (ARI) - Child	Change over baseline and weeks 4 and 5.	A child completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity.
Affective Reactivity Index (ARI) - Parent Report	Change over baseline and weeks 4 and 5.	A parent completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity.
Multidimensional Anxiety Scale for Children (MASC) - Child Report	Change over baseline and weeks 4 and 5.	A child completed rating of child anxiety, with scores ranging from 0-300, and higher scores indicating greater severity.
Multidimensional Anxiety Scale for Children (MASC) - Parent Report	Change over baseline and weeks 4 and 5.	A parent completed rating of child anxiety, with scores ranging from 0-300, and higher scores indicating greater severity.
Height	Change over baseline and weeks 1, 4, and 5.	A dimensional measure assessed in centimeters (cm).
Weight	Change over baseline and weeks 1, 4, and 5.	A dimensional measure assessed in kilograms (kg).
Systolic Blood Pressure	Change over baseline and weeks 1, 4, and 5.	A dimensional measure expressed in mm mercury (Hg).
Diastolic Blood Pressure	Change over baseline and weeks 1, 4, and 5.	A dimensional measure assessed in mm mercury (Hg).
Pulse	Change over baseline and weeks weeks 1, 4, and 5.	Heart rate in beats per minute (bpm).
Children's Depression Inventory (CDI)	Change over baseline and weeks 4 and 5.	A child completed self-report dimensional measure of depressive symptoms, with range of scores from 0 to 54. Higher scores reflect increasing depression. Cutoff scores \< 17 to 20 are generally considered to be in the normative range. A score of 36 or higher reflects a relatively severe depression.
Conners Global Index - Teacher	Change over baseline and weeks 1, 2, 3, 4, 5.	Teacher completed dimensional measure of ADHD symptoms, with scores ranging from 0-30, and higher scores indicating more severe symptoms.

Trial Locations

Locations (1)

UCLA Semel Institute; 🇺🇸 Los Angeles, California, United States