Functional MRI Study in Healthy Children Engaged in Aggressive Behaviors

Sponsor
Supernus Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03615703
Collaborator
(none)
17
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7.1
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Study Details

Study Description

Brief Summary

The purpose of this non-interventional study is to optimize the point subtraction aggression paradigms (PSAP) task in typically developing children (TDC).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The PSAP is a behavioral aggression test used to evaluate behavioral response related to impulsive aggression. The task will be combined with functional MRI to establish a reliable BOLD signal during testing in developing healthy subjects (8-12 years old) and, to determine the feasibility to perform the task.

    Additionally, the levels of neurotransmitters Glutamate and GABA will be measured using magnetic resonance spectroscopy (MRS).

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    17 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    Functional Neuroimaging Study to Validate the Point Subtraction Aggression Paradigm (PSAP) Task in Typically Developing Children (TDC) Aged 8-12 Years
    Actual Study Start Date :
    Aug 10, 2018
    Actual Primary Completion Date :
    Mar 15, 2019
    Actual Study Completion Date :
    Mar 15, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Brain Imaging in typically developing healthy children during the PSAP aggression Task [The study consist of one visit (total time-2 hrs.).]

      The study has only one visit (approximately 2 hours). During the task each participant competes against a fictitious opponent (a computer in reality) to earn points. The participant will play a computer game in which they can steal points (simulating an aggressive behavior) or have points stolen by the opponent. 10 healthy subjects will be recruited for the study. To make the participant feel comfortable in the MRI, eligible subjects will spend time first to habituate to the scanner and then practice the task. The complete MRI will last one and half hour (at most). Functional imaging data (neural activation) will be collected during the behavioral aggression task, while playing the game. In addition, imaging data will be collected at resting state to understand the connectivity between regions of interest before and after the aggression task.

    Secondary Outcome Measures

    1. GABA and Glutamate Levels [The study consist of one visit (total time-2 hrs.).]

      During the MRI scan, imaging data will be obtained while participants are able to listen to music. GABA and Glutamate signals measured using magnetic resonance spectroscopy (MRS) from two brain regions (anterior cingulate cortex and amygdala) will be used to quantify the two neurotransmitters.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    Healthy male or female subjects, aged 8-12 years (inclusive) at the time of screening.

    Exclusion Criteria:
    1. Current history of developmental, psychiatric, or neurologic disorder, including seizures (except for uncomplicated brief febrile seizures), tumor, severe head injury/traumatic brain injury, stroke, lesion, or disease.

    2. Known or suspected intelligence quotient (IQ) <70, diagnosis of mental retardation or cerebral palsy or speech/language disorder and history of implanted brain stimulator, vagal nerve stimulator, ventriculoperitoneal shunt, cardiac pacemaker, orthodontic braces, or implanted medication port.

    3. Visual and hearing (≥25 dB) impairment.

    4. Pre-existing medical or psychological conditions that preclude being in the MRI scanner (e.g., claustrophobia, morbid obesity, or marked anxiety about the procedure).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Meridien Research, Inc. Orlando Florida United States 32751

    Sponsors and Collaborators

    • Supernus Pharmaceuticals, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Supernus Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT03615703
    Other Study ID Numbers:
    • 810P204a
    First Posted:
    Aug 6, 2018
    Last Update Posted:
    Jun 10, 2019
    Last Verified:
    Feb 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 10, 2019