NCT04349917

Large-scale Brain Organization During Cognitive Control in ADHD

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 8 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	Methylphenidate	A single, low dose of methylphenidate (0.3 mg/kg) will be administered on the drug day.
OTHER	Placebo	A matching placebo pill will be administered on the placebo day.

Timeline

• Start date: 2016-12-16
• Primary completion: 2020-03-14
• Completion: 2020-03-14
• First posted: 2020-04-16
• Last updated: 2021-01-12
• Results posted: 2021-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study