Functional MRI Study in Healthy Children Engaged in Aggressive Behaviors

• ClinicalTrials.gov Identifier: NCT03615703
• Recruitment Status: Completed
• First Posted: August 6, 2018
• Last Update Posted: June 10, 2019
• Sponsor: Supernus Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Supernus Pharmaceuticals, Inc.

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
Impulsive Aggression

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: August 10, 2018
• Actual Primary Completion Date: March 15, 2019
• Actual Study Completion Date: March 15, 2019

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 8 Years to 12 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Healthy Volunteers

Criteria

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

United States, Florida

Meridien Research, Inc.

Orlando, Florida, United States, 32751

Sponsors and Collaborators

Supernus Pharmaceuticals, Inc.

More Information

Publications:

Cherek DR, Moeller FG, Schnapp W, Dougherty DM. Studies of violent and nonviolent male parolees: I. Laboratory and psychometric measurements of aggression. Biol Psychiatry. 1997 Mar 1;41(5):514-22.

Bubenzer-Busch S, Herpertz-Dahlmann B, Kuzmanovic B, Gaber TJ, Helmbold K, Ullisch MG, Baurmann D, Eickhoff SB, Fink GR, Zepf FD. Neural correlates of reactive aggression in children with attention-deficit/hyperactivity disorder and comorbid disruptive behaviour disorders. Acta Psychiatr Scand. 2016 Apr;133(4):310-23. doi: 10.1111/acps.12475. Epub 2015 Aug 21.

• Responsible Party: Supernus Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT03615703
• Other Study ID Numbers: 810P204a
• First Posted: August 6, 2018
• Last Update Posted: June 10, 2019
• Last Verified: February 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Aggression; Behavioral Symptoms