Trigeminal Nerve Stimulation for ADHD
Completed · Not applicable · Has a placebo group
Conditions studied: Attention Deficit Hyperactivity Disorder (ADHD)
In brief
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.
Key facts
- Study ID
- NCT02155608
- Run by
- University of California, Los Angeles
- People needed
- 62
- Starts
- 2015-04-01
- Expected to finish
- 2018-05-30
- Last updated by the study team
- 2019-07-02
Who can join
Age: 8 and older, up to 12. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- UCLA Semel Institute — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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