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

January 13, 2025 updated by: Alexander Cohen, Boston Children's Hospital

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Brookline, Massachusetts, United States, 02445
        • Boston Children's Hospital @2BP
        • Contact:
        • Contact:
          • Meghan Walsh, B.A.
        • Contact:
          • Sofia Heras, B.S.
        • Contact:
          • Alexander Cohen, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through data collection and analysis, an average of 1 year
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.
Through data collection and analysis, an average of 1 year
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.
Through data collection and analysis, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 13, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-P00049401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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