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

Официальное название

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

Обзор

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

Вмешательства

• Комбинированный продукт 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.

Первичные конечные точки

• Neurofeedback mimicking the effects of stimulants [Срок оценки: Through data collection and analysis, an average of 1 year]
• Performance on Attentive Tasks [Срок оценки: Through data collection and analysis, an average of 1 year]
• Precise motion correction as a better accountant of ADHD mechanisms [Срок оценки: Through data collection and analysis, an average of 1 year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Boston Children's Hospital @2BP — Brookline

Публикации

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• Rubia K, Alegria AA, Cubillo AI, Smith AB, Brammer MJ, Radua J. Effects of stimulants on brain function in attention-deficit/hyperactivity disorder: a systematic review and meta-analysis. Biol Psychiatry. 2014 Oct 15;76(8):616-28. doi: 10.1016/j.biopsych.2013.10.016. Epub 2013 Oct 24. PMID 24314347
• Sitaram R, Ros T, Stoeckel L, Haller S, Scharnowski F, Lewis-Peacock J, Weiskopf N, Blefari ML, Rana M, Oblak E, Birbaumer N, Sulzer J. Closed-loop brain training: the science of neurofeedback. Nat Rev Neurosci. 2017 Feb;18(2):86-100. doi: 10.1038/nrn.2016.164. Epub 2016 Dec 22. PMID 28003656
• Fair DA, Nigg JT, Iyer S, Bathula D, Mills KL, Dosenbach NU, Schlaggar BL, Mennes M, Gutman D, Bangaru S, Buitelaar JK, Dickstein DP, Di Martino A, Kennedy DN, Kelly C, Luna B, Schweitzer JB, Velanova K, Wang YF, Mostofsky S, Castellanos FX, Milham MP. Distinct neural signatures detected for ADHD subtypes after controlling for micro-movements in resting state functional connectivity MRI data. Fron PMID 23382713

Идентификаторы

NCT: NCT06779825 · IRB-P00049401

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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