Early Phase 1
N=25
Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)
Attention-Deficit/Hyperactivity Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01388530 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: ADHD-IV Rating Scale (ADHD-RS) — 32.6 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- EMS 7500 Digital Muscle Stimulator (Device)
- Age
- Pediatric · 7+ yrs
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ADHD-IV Rating Scale (ADHD-RS) |
32.6 | — |
| SECONDARY Clinical Global Impression - Improvement (CGI-I) |
67 | — |
| SECONDARY Conners Global Index - Parent |
19.6 | — |
| SECONDARY Attention Network Task - Incongruent Reaction Time |
902.9 | — |
Summary
This proposal seeks to obtain preliminary data on the potential efficacy, tolerability, and feasibility of trigeminal nerve stimulation (TNS) as a treatment for Attention-Deficit/Hyperactivity Disorder (ADHD). If successful, this open-label, exploratory, pilot study will provide a basis for a federal grant application and larger controlled trials.
Eligibility Criteria
Inclusion Criteria
- male and female youth age 9 to 14 years with Diagnostic and Statistical Manuel -IV (DSM-IV) ADHD, combined subtype as determined by Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS) and clinical interview
- minimum scores of 12 on both the inattentive and hyperactive/impulsive subscales of the baseline ADHD-Rating Scale (ADHD-RS)S
- Clinical Global Impression- Severity (CGI-S) score at baseline
- no current medications with central nervous system (CNS) affects
- parents able and willing to monitor proper use of the stimulation device and complete all required rating scales.
Exclusion Criteria
- impaired functioning to a degree that requires immediate initiation of ADHD medication in the opinion of the parents and/or investigator; 2) current diagnosis of pervasive developmental disorder or major depression.
- history of lifetime psychosis or mania
- current suicidality
- history of seizure disorder, tic disorder, or head injury with loss of consciousness.
Data sourced from ClinicalTrials.gov (NCT01388530). 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.