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

Part of paid clinical trials in Brookline, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT06779825
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 35 Years
Healthy Volunteers
Not accepted

Interventions

  • fMRI Neurofeedback attention task — COMBINATION_PRODUCT
    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.

Study Details

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

Key Dates

Start date
Feb 28, 2025
Status verified
Jan 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Stimulant Medication for ADHD
    Arm 1 will require that all participants refrain from taking their usual ADHD stimulant medication on the day of at least two of the study visits, one of which includes neurofeedback. Participants may resume their medication regimen upon completion of the study visit.

Primary Outcome Measure

Neurofeedback mimicking the effects of stimulants [ Time Frame: Through data collection and analysis, an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's Hospital @2BPBrooklineMassachusetts02445
Alexander Cohen, MD, PhD
[email protected]
617-355-6000
Meghan Walsh, B.A.
Sofia Heras, B.S.
Alexander Cohen, MD, PhD

Find similar trials in Brookline, MA

By condition
ADHD
By specialty
PsychiatryMental healthBehavioral health
By research site
Boston Children's Hospital @2BP· Brookline, MA

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