Impact of Stimulants and In-Scanner Motion on Attentive Task Performance in ADHD (ADHD_NFB)
NCT ID: NCT06779825
Last Updated: 2025-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
30 participants
OBSERVATIONAL
2025-02-28
2026-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
35 Years
ALL
No
Sponsors
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Boston Children's Hospital
OTHER
Responsible Party
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Alexander Cohen
Principal Investigator and Medical Physician
Locations
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Boston Children's Hospital @2BP
Brookline, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Meghan Walsh, B.A.
Role: backup
Sofia Heras, B.S.
Role: backup
Alexander Cohen, MD, PhD
Role: backup
References
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Hein IM, De Vries MC, Troost PW, Meynen G, Van Goudoever JB, Lindauer RJ. Informed consent instead of assent is appropriate in children from the age of twelve: Policy implications of new findings on children's competence to consent to clinical research. BMC Med Ethics. 2015 Nov 9;16(1):76. doi: 10.1186/s12910-015-0067-z.
Isles AF. Understood consent versus informed consent: a new paradigm for obtaining consent for pediatric research studies. Front Pediatr. 2013 Nov 21;1:38. doi: 10.3389/fped.2013.00038.
Sulzer J, Haller S, Scharnowski F, Weiskopf N, Birbaumer N, Blefari ML, Bruehl AB, Cohen LG, DeCharms RC, Gassert R, Goebel R, Herwig U, LaConte S, Linden D, Luft A, Seifritz E, Sitaram R. Real-time fMRI neurofeedback: progress and challenges. Neuroimage. 2013 Aug 1;76:386-99. doi: 10.1016/j.neuroimage.2013.03.033. Epub 2013 Mar 27.
Wu ZM, Bralten J, An L, Cao QJ, Cao XH, Sun L, Liu L, Yang L, Mennes M, Zang YF, Franke B, Hoogman M, Wang YF. Verbal working memory-related functional connectivity alterations in boys with attention-deficit/hyperactivity disorder and the effects of methylphenidate. J Psychopharmacol. 2017 Aug;31(8):1061-1069. doi: 10.1177/0269881117715607. Epub 2017 Jun 28.
Berberat J, Huggenberger R, Montali M, Gruber P, Pircher A, Lovblad KO, Killer HE, Remonda L. Brain activation patterns in medicated versus medication-naive adults with attention-deficit hyperactivity disorder during fMRI tasks of motor inhibition and cognitive switching. BMC Med Imaging. 2021 Mar 19;21(1):53. doi: 10.1186/s12880-021-00579-3.
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.
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.
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. Front Syst Neurosci. 2013 Feb 4;6:80. doi: 10.3389/fnsys.2012.00080. eCollection 2012.
Dziemian S, Baranczuk-Turska Z, Langer N. Association between attention-deficit/hyperactivity disorder symptom severity and white matter integrity moderated by in-scanner head motion. Transl Psychiatry. 2022 Oct 6;12(1):434. doi: 10.1038/s41398-022-02117-3.
Couvy-Duchesne B, Ebejer JL, Gillespie NA, Duffy DL, Hickie IB, Thompson PM, Martin NG, de Zubicaray GI, McMahon KL, Medland SE, Wright MJ. Head Motion and Inattention/Hyperactivity Share Common Genetic Influences: Implications for fMRI Studies of ADHD. PLoS One. 2016 Jan 8;11(1):e0146271. doi: 10.1371/journal.pone.0146271. eCollection 2016.
Makowski C, Lepage M, Evans AC. Head motion: the dirty little secret of neuroimaging in psychiatry. J Psychiatry Neurosci. 2019 Jan 1;44(1):62-68. doi: 10.1503/jpn.180022.
Yakupov R, Lei J, Hoffmann MB, Speck O. False fMRI activation after motion correction. Hum Brain Mapp. 2017 Sep;38(9):4497-4510. doi: 10.1002/hbm.23677. Epub 2017 Jun 5.
Related Links
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Lab website giving a brief description of study protocol for those interested in participating.
Other Identifiers
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IRB-P00049401
Identifier Type: -
Identifier Source: org_study_id
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