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Completed

NCT Number: NCT03615703

Functional MRI Study in Healthy Children Engaged in Aggressive Behaviors

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

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Key information

Conditions

Impulsive Aggression

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Meridien Research, Inc.

Orlando, Florida, 32751, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.
  • 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.
  • Visual and hearing (≥25 dB) impairment.
  • Pre-existing medical or psychological conditions that preclude being in the MRI scanner (e.g., claustrophobia, morbid obesity, or marked anxiety about the procedure).

Treatment and study plan

Primary outcomes

  1. Brain Imaging in typically developing healthy children during the PSAP aggression Task

    Time frame: 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 outcomes

  1. GABA and Glutamate Levels

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Supernus Pharmaceuticals, Inc.

Industry

Registry information

Official study title

Functional Neuroimaging Study to Validate the Point Subtraction Aggression Paradigm (PSAP) Task in Typically Developing Children (TDC) Aged 8-12 Years

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 6, 2018
Registry last updated
Jun 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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