ADHDADHD_NFBNCT06779825
Impact of Stimulants and In-Scanner Motion on Attentive Task Performance in ADHD (ADHD_NFB)
An observational study of ADHD, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 35 years
- Conditions the study is for
- ADHD
- What is being tested?
- fMRI Neurofeedback attention task
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2025to Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Boston Children's Hospital @2BP
Brookline, Massachusetts, 02445
Alexander Cohen, MD, PhD, 617-355-6000, alexander.cohen2@childrens.harvard.edu
Meghan Walsh, B.A.
About this study
Official title: 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:
- How do the use of stimulants affect brain activity and motion in fMRI research in ADHD studies?
- Can neurofeedback, an attentive task using real-time brain activity, engage the same brain circuits as seen with stimulant medication in individuals with ADHD?
Read more
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:
- Be asked to complete at least 4 fMRI sessions, two of which will include neurofeedback
- Be asked to abstain from taking stimulant medication on the day of two of these fMRI visits
- Complete attentive tasks while in the scanner that will activate target brain regions of interest
- Conditions
- ADHD
- Being tested
- fMRI Neurofeedback attention task
- Keywords
- ADHD, Neurofeedback, fMRI, attention tasks, motion
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRI Neurofeedback attention taskCombination product
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: fMRI Neurofeedback attention task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurofeedback mimicking the effects of stimulants
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.
Measured: Through data collection and analysis, an average of 1 year
Performance on Attentive Tasks
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.
Measured: Through data collection and analysis, an average of 1 year
Precise motion correction as a better accountant of ADHD mechanisms
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.
Measured: Through data collection and analysis, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study startFeb 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Cohen, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779825
- Sponsor's protocol ID
- IRB-P00049401
- Acronym
- ADHD_NFB
- Status last verified
- Jan 2025
- First submitted
- 9 Jan 2025
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 26553304Isles 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.
PubMed 24400284Sulzer 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.
PubMed 23541800Wu 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.
PubMed 28656805Berberat 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.
PubMed 33740903Rubia 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.
PubMed 24314347Sitaram 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.
PubMed 28003656Fair 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.
PubMed 23382713Dziemian 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.
PubMed 36202807Couvy-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.
PubMed 26745144Makowski 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.
PubMed 30565907Yakupov 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.
PubMed 28580597