N/A
N=62
Trigeminal Nerve Stimulation for ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
Bottom Line
View on ClinicalTrials.gov: NCT02155608 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: ADHD-IV Rating Scale (ADHD-RS) — 32.12; 32.83; 26.16; 28.53 score on a scale — p=.54
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active eTNS (Device); Sham eTNS (Device)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ADHD-IV Rating Scale (ADHD-RS) |
32.12; 32.83; 26.16; 28.53; 24.74; 28.31 | .54 |
| SECONDARY Clinical Global Impression - Improvement (CGI-I) |
8; 4; 24; 26; 12; 4 | .003 sig |
| SECONDARY Conners Global Index - Parent Report |
18.3; 17.4; 15.7; 16.5; 13.0; 15.2 | .91 |
| SECONDARY Affective Reactivity Index (ARI) - Child |
4.5; 4.5; 4.1; 3.8; 3.9; 3.5 | .91 |
| SECONDARY Affective Reactivity Index (ARI) - Parent Report |
4.4; 4.5; 3.6; 3.6; 3.8; 4.2 | .89 |
| SECONDARY Multidimensional Anxiety Scale for Children (MASC) - Child Report |
61.0; 61.0; 59.5; 56.4; 56.1; 52.3 | .91 |
| SECONDARY Multidimensional Anxiety Scale for Children (MASC) - Parent Report |
46.2; 48.4; 33.9; 42.9; 32.4; 38.2 | .62 |
| SECONDARY Height |
142.82; 141.45; 142.79; 141.57; 143.14; 142.31 | .29 |
| SECONDARY Weight |
38.83; 35.34; 39.12; 35.58; 39.65; 35.67 | .21 |
| SECONDARY Systolic Blood Pressure |
108.50; 106.10; 107.03; 109.20; 111.00; 107.79 | .94 |
| SECONDARY Diastolic Blood Pressure |
64.97; 63.61; 63.69; 62.33; 65.09; 61.01 | .64 |
| SECONDARY Pulse |
76.69; 76.70; 79.91; 79.70; 81.78; 75.18 | .79 |
| SECONDARY Children's Depression Inventory (CDI) |
10.14; 9.10; 8.94; 8.21; 7.88; 7.34 | .55 |
| SECONDARY Conners Global Index - Teacher |
15.76; 15.15; 15.86; 11.37; 14.36; 15.64 | .21 |
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.
Eligibility Criteria
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
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
Data sourced from ClinicalTrials.gov (NCT02155608). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.