NCT06779825

Impact of Stimulants and In-Scanner Motion on Attentive Task Performance in ADHD (ADHD_NFB)

Impact of Stimulants and In-Scanner Motion on FMRI Neurofeedback and Task Performance in ADHD

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 12 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

The goal of this interventional study is to learn the effects that stimulant medication prescribed to ADHD individuals has in their performance of attentive tasks, as measured by images and data collected through neuroimaging (fMRI) while also implementing new motion-correcting software. The main questions it aims to answer are: 1. How do the use of stimulants affect brain activity and motion in fMRI research in ADHD studies? 2. Can neurofeedback, an attentive task using real-time brain activity, engage the same brain circuits as seen with stimulant medication in individuals with ADHD? Researchers will compare participant's brain activity from the completion of attentive tasks performed in the scanner while following their regular medication regimen and while abstaining to take medication. Researchers will also compare how the data collected using a more precise motion correction software differs to other previously reported data from ADHD studies who possibly employed more lenient measures of motion correction. Participants will: 1. Be asked to complete at least 4 fMRI sessions, two of which will include neurofeedback 2. Be asked to abstain from taking stimulant medication on the day of two of these fMRI visits 3. Complete attentive tasks while in the scanner that will activate target brain regions of interest

Conditions

• ADHD

Interventions

Type	Name	Description
COMBINATION_PRODUCT	fMRI Neurofeedback attention task	Neurofeedback is an attentive task where participants are shown their real-time brain signals while in the scanner with the use of a representation, such as a rocket moving towards a portal. Participants are able to increase this brain signal by more purposefully engaging certain brain regions, and this is reflected in the representation that they see. Ultimately, this study is interested in whether neurofeedback can replicate the effects of stimulant medication in ADHD.

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2025-01-17
• Last updated: 2025-01-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study