View Clinical Trial (Medical Research Study)
An Eight-Week, Open Trial Pilot Investigation of Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)
| City: |
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Los Angeles |
| State: |
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California |
| Zip Code: |
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90095 |
| Conditions: |
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Attention-Deficit/Hyperactivity Disorder |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- male and female youth age 9 to 14 years with 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-RS
- 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.
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| NCT ID: |
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NCT01388530 |
| Primary Contact: |
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James J. McGough, M.D.
Phone: 310-794-7841
Email: jmcgough@mednet.ucla.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Los Angeles, California 90095
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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