Clinical trial NCT04349917: Large-scale Brain Organization During Cognitive Control in ADHD
Official title: Large-scale Brain Organization During Cognitive Control in ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: methylphenidate
functional connectivity
graph theory
cognitive control
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-04-16
Enrollment: 37
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, double-blind, placebo-controlled, crossover design. Each subject with ADHD participates in two sessions, one on drug and one on placebo (order randomized ). Both subjects and experimenters are blind to the order.
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to test whether children with attention-deficit/hyperactivity disorder (ADHD) are impaired in the ability to flexibly adapt brain network organization in response to shifting cognitive demands during the exertion of cognitive control, by assessing changes in network dynamics resulting from stimulant administration in children with ADHD, and how those changes relate to behavioral and symptom improvements. Subjects will be children with ADHD aged 8-12. Subjects will participate in multiple testing sessions that include: diagnosis and eligibility screening, neuropsychological and behavioral testing, and, if eligible, MRI scans and a medication challenge. Children with ADHD who are enrolled in the medication challenge will undergo one MRI scan on placebo and one MRI scan on stimulant medication, counterbalanced and double-blind. Functional connectivity will be measured using functional MRI and innovative graph theoretical analytic tools will be implemented. Network metrics will be related to symptomatology and behavioral testing measures. It is hypothesized that stimulant administration in children with ADHD will increase flexibility in network reconfiguration in response to changing cognitive control demands as compared to when they are on placebo. It is further hypothesized that the degree to which brain network organization is changed will be related to the degree of improvement in cognitive control performance.


Eligibility criteria: Inclusion Criteria:

* Between 8-12 years old
* Diagnosis of ADHD (for ADHD group); ADHD group only can have comorbid Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnoses of oppositional defiant disorder, conduct disorder, depressive disorders, or anxiety disorders
* ADHD subjects must never have been treated with medication for their ADHD

Exclusion Criteria:

* Wechsler Intelligence Scale for Children-Fifth Edition Full-Scale Intelligence Quotient (IQ) \< 80
* Wechsler Individual Achievement Test-Third Edition Word Reading \< 85
* Any neurologic or developmental disabilities
* Any reading or learning disabilities
* Visual impairment that cannot be corrected-to-normal
* Color blindness
* Documented hearing impairment greater than 25 decibels (dB) loss in either year
* Have already gone through puberty (Tanner Stage II or higher)
* Medical contraindication to MRI
* Any psychoactive medication

Primary outcomes:
measure: Resting State Brain Network Organization
timeFrame: 1 to 3 hours after administration of intervention
measure: Task-Based Brain Network Organization
timeFrame: 1 to 3 hours after administration of intervention
measure: Rest-Task Reconfiguration
timeFrame: 1 to 3 hours after administration of intervention
measure: Drug-induced Normalization
timeFrame: 1 to 3 hours after administration of intervention
Secondary outcomes:
measure: Go/No-go (GNG) Commission Rate
timeFrame: 1 to 3 hours after administration of intervention
measure: Go/No-go (GNG) Omission Rate
timeFrame: 1 to 3 hours after administration of intervention
measure: Go/No-go (GNG) Response Time Variability
timeFrame: 1 to 3 hours after administration of intervention
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Jessica R Cohen, PhD
role: PRINCIPAL_INVESTIGATOR
References: