Clinical trial NCT06779825: Impact of Stimulants and In-Scanner Motion on Attentive Task Performance in ADHD (ADHD_NFB)
Official title: Impact of Stimulants and In-Scanner Motion on FMRI Neurofeedback and Task Performance in ADHD
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: ADHD
Keywords: ADHD
Neurofeedback
fMRI
attention tasks
motion
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be largely recruited through the Boston Children Hospital's resources, such as a participant registry or from clinical practice, only applicable to individuals who fit the eligibility criteria listed above.

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


Eligibility criteria: 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

Primary outcomes:
measure: Neurofeedback mimicking the effects of stimulants
timeFrame: Through data collection and analysis, an average of 1 year
measure: Performance on Attentive Tasks
timeFrame: Through data collection and analysis, an average of 1 year
measure: Precise motion correction as a better accountant of ADHD mechanisms
timeFrame: Through data collection and analysis, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Brookline
country: United States
facility: Boston Children's Hospital @2BP
state: Massachusetts
Study officials:
References:
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