Functional MRI Study in Healthy Children Engaged in Aggressive Behaviors



Status:Recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:8 - 12
Updated:3/6/2019
Start Date:August 10, 2018
End Date:July 30, 2019
Contact:Ronald Marcus, MD
Email:rmarcus@supernus.com
Phone:301-838-2569

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

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

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).

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).
We found this trial at
1
site
2300 Maitland Center Parkway
Orlando, Florida 32810
?
mi
from
Orlando, FL
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