Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)
Completed · Early Phase 1
Conditions studied: Attention-Deficit/Hyperactivity Disorder
In brief
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.
Key facts
- Study ID
- NCT01388530
- Run by
- University of California, Los Angeles
- People needed
- 25
- Starts
- 2011-07-01
- Expected to finish
- 2012-12-01
- Last updated by the study team
- 2016-04-11
Who can join
Age: 7 and older, up to 14. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
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; 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.
Where it is running
- UCLA — Los Angeles, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.