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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06779825
Acronym
ADHD_NFB
Enrollment
30
Registered
2025-01-17
Start date
2025-02-28
Completion date
2026-12-31
Last updated
2025-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD

Keywords

ADHD, Neurofeedback, fMRI, attention tasks, motion

Brief 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

Interventions

COMBINATION_PRODUCTfMRI 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.

Sponsors

Boston Children's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to 35 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Neurofeedback mimicking the effects of stimulantsThrough data collection and analysis, an average of 1 yearCompare 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 TasksThrough data collection and analysis, an average of 1 yearPerformance 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 mechanismsThrough data collection and analysis, an average of 1 yearWill 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.

Countries

United States

Contacts

Primary ContactAlexander Cohen, MD, PhD
alexander.cohen2@childrens.harvard.edu617-355-6000
Backup ContactCohen Lab
CohenLab@childrens.harvard.edu617-355-6388

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026