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NCT Number: NCT06779825

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

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

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

12 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hospital @2BP

Brookline, Massachusetts, 02445, United States

Location contact

Alexander Cohen, MD, PhD

CONTACT

[email protected]

617-355-6000

Alexander Cohen, MD, PhD

CONTACT

Meghan Walsh, B.A.

CONTACT

Sofia Heras, B.S.

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 12 or older
Able to follow verbal and written instructions in native language
Pre-existing clinical ADHD diagnosis (with or without comorbid anxiety diagnoses)
Pre-existing medication regimen of methylphenidate or amphetamine salt derivatives with no changes in the last month

Exclusion criteria

Known visual impairment preventing test administration
Contraindication of inability to participate in fMRI scanning (per MRI screening form)
Known, self-reported non-incidental structural brain abnormality
Autism Spectrum Disorder or Obsessive-Compulsive Disorder
Non-verbal

Treatment and study plan

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.

Primary outcomes

Neurofeedback mimicking the effects of stimulants

Time frame: Through data collection and analysis, an average of 1 year

Compare whether neurofeedback can mimic the effects of stimulants by engaging similar attentive brain circuits and providing a normalized activation effect similar to that of stimulants (measured in units of neural activation, with intensity based on p-value of significance, and by a z-score obtained in real-time during the task). This data will be collected during the completion of the neurofeeback task while in the scanner.
Performance on Attentive Tasks

Time frame: Through data collection and analysis, an average of 1 year

Performance on other attentive tasks (e.g., reaction time in seconds, accuracy of response), different from neurofeedback, will be observed while on stimulant medication, compared to performance on the same tasks while refraining from stimulant medication.
Precise motion correction as a better accountant of ADHD mechanisms

Time frame: Through data collection and analysis, an average of 1 year

Will compare results from data collected using fMRI and a new software that more precisely corrects for motion artifacts in a slice-by-slice manner to results previously reported for ADHD studies using more lenient fMRI motion artifact measures. Some of these comparisons will include more or less brain activation of the same regions, more precise windows of activation, etc.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Cohen, MD, PhD

CONTACT

[email protected]

617-355-6000

Cohen Lab

CONTACT

[email protected]

617-355-6388

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

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

Acronym: ADHD_NFB

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jan 17, 2025
Registry last updated: Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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