Functional MRI Study in Healthy Children Engaged in Aggressive Behaviors

Completed

• Conditions: Impulsive Aggression

• Registration Number: NCT03615703
• Lead Sponsor: Supernus Pharmaceuticals, Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-07-24
• Study First Submitted QC: 2018-07-30
• Study First Posted: 2018-08-06
• Study Start: 2018-08-10
• Status Verified: 2019-02
• Primary Completion: 2019-03-15
• Study Completion: 2019-03-15
• Last Update Submitted: 2019-06-07
• Last Update Posted: 2019-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Meridien Research, Inc.; 🇺🇸 Orlando, Florida, United States