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EEG Biomarkers for ADHD Stimulant Treatment

12 czerwca 2026 zaktualizowane przez: Anne Arnett, Boston Children's Hospital

EEG Biomarkers for Pediatric ADHD Treatment Stratification

Pediatric attention deficit hyperactivity disorder (ADHD) affects up to 10% of children in the U.S. and more than 90% are prescribed stimulant medications according to clinical guidelines. The standard of care for pharmacological treatment of ADHD is a "trial-and-error" approach that requires frequent dose adjustments, side effects management, and communication among doctors, parents, and school personnel over weeks, months, and years. In the first year following prescription of stimulant medications, >50% of doctors are not able to conduct the recommended follow-up with their patients. Many patients stop taking medications or keep taking medications that do not work well, as a result.

This investigation will use a non-invasive brain imaging technique called EEG to look for activity in the brain that can predict which children with ADHD will respond well to two commonly prescribed stimulant medication groups, methylphenidate and amphetamines. Based on a previous study, it is expected that EEG signals can differentiate among children whose ADHD symptoms will get better on methylphenidate, and those whose ADHD symptoms will get better on amphetamines.

220 participants ages 7-11 with ADHD will be enrolled. Participants will not have autism or intellectual disabiltiy. They will not currently be taking psychiatric medications. Participants will not have not taken stimulant medications before or have tried stimulant medications >6 months or experienced an improvement in their ADHD symptoms by taking a stimulant medication before.

Study Participation Includes:

  1. Participant and caregiver complete a 3-hour visit at the Arnett Laboratory at 2 Brookline Place. During this visit, participants complete a brief IQ test and an EEG while their caregiver completes questionnaires and a clinical interview. The caregiver will give permission to request survey responses from the participant's teacher.
  2. The next day, the participant and caregiver will come back to the laboratory for a 1-hour visit. The participant will do another EEG while the caregiver fills out more surveys. The doctor will take the participant's vital signs and prescribe the medication.
  3. The participant will be randomly assigned to take either methylphenidate HCl or amphetamines every morning for 3 weeks. At the end of each week, the caregiver and teacher will fill out a questionnaire about the participant's behaviors and symptoms, including side effects.
  4. For one week, the participant will not take medications. They will come back into the lab for another EEG at the end of that week.
  5. The participant will then take the other medication every morning for 3 weeks. At the end of each week, the caregiver and teacher will fill out a questionnaire about the participant's behaviors and symptoms, including side effects.
  6. It will take participants about 7 weeks to complete this study. During this time, they will complete 3 in-person and 6 virtual study visits.
  7. The research funds will cover cost associated with the study. The participant's health insurer will not be billed for the medications or treatment. Medications will be provided through the research pharmacy.
  8. Participants will be given a report at the end of the study with details about the medication trials, symptom response, and any other findings. They will receive up to $270 for the completion of the study. Some travel-related costs will be covered by the study.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

Pediatric attention deficit hyperactivity disorder (ADHD) affects up to 10% of children in the U.S. and more than 90% are prescribed stimulant medications according to clinical guidelines. The standard of care for pharmacological treatment of ADHD is a "trial-and-error" approach that requires frequent titration, side effects management, and communication among providers, parents, and school personnel over weeks, months, and years. This level of effort often exceeds the capacity of primary care providers, who manage treatment for the majority of affected children. In the first year following stimulant prescription, recommended routine follow-up occurs in <50% of cases treated in primary care. Consequently, suboptimal dosing and early discontinuation of stimulants are exceedingly common, with >75% pediatric ADHD patients showing suboptimal medication adherence in the first year.

The current proposal will utilize electroencephalography (EEG), a non-invasive, affordable brain measurement tool, to characterize predictive biomarkers for response to two commonly prescribed stimulant medication classes: methylphenidate (MPH) and amphetamines (AMP). Predictive biomarkers can be used to guide clinical decision making and treatment selection for pediatric ADHD, ultimately shortening the time from diagnosis to treatment optimization; reducing burden on clinicians, families, and teachers; and leading to better lifetime outcomes for children with ADHD. Thus far, behavioral- and genomic-based treatment biomarkers have not been successful for ADHD, and there is increasing demand by patients and providers to identify a solution.

Building on our pilot data, this study will constitute a prospective, single-blind, double-baseline randomized MPH-AMP crossover trial with 220 treatment-naïve, 7-11-year-old children with ADHD. EEG will be collected prior to each medication arm, and treatment response will be determined using 3-week rapid titration protocols, consistent with our pilot study and other published trials. Trained clinicians will characterize each participant as a "responder" or "non-responder" for each medication.

EEG features with small to medium effect sizes that are predictive of positive response to MPH and AMP will be identified. Preliminary data suggest MPH and AMP will have distinct EEG predictive biomarkers. To further examine the translational potential of these results, test-retest reliability and classification agreement of biomarkers over 24 hours and 4 weeks will be estimated. Results of this study have potential to accelerate pediatric mental health treatment development and precision medicine care for ADHD.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

220

Faza

  • Faza 4

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  1. Ages 7:0 - 10:11 (years:months)
  2. Has a diagnosis of ADHD or being evaluated for ADHD
  3. Stimulant naïve or previously trialed stimulant medications for < 6 months without achieving symptom remission, per caregiver report and/or medical chart review (if available)
  4. CGI-Severity rating of 4 "Moderately ill" through 6 "Severely ill."
  5. Willing and able to comply with study procedures

Exclusion Criteria:

  1. Use of stimulants or other psychotropic medications within 7 days before Eligibility Visit
  2. History of severe side effects to stimulants (suicidality, complete loss of appetite, cardiopulmonary complications) per caregiver report or medical chart review, determined by the study MD
  3. Intellectual disability or IQ < 75 per medical chart review or performance on standardized cognitive testing during the Eligibility Visit
  4. Diagnosis of Autism spectrum disorder (ASD) per medical chart review or caregiver report
  5. Fetal alcohol exposure per medical chart review or caregiver report
  6. Current suicidal ideation per caregiver or child report on CSSRS
  7. Non-febrile seizures per caregiver report or medical chart review
  8. Cardiopulmonary conditions, pregnancy or other medical conditions that contraindicate psychostimulant use per determination by the study MD

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie krzyżowe
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Methylphenidate HCl then Mixed Amphetamines
Participants in the first Arm will complete a 3-week titration of Methylphenidate HCl (Quillivant XR, 25mg/5mL). Doses will be increased at the end of each week using the following schedule: week 1 2mL; week 2 4mL; week 3 6mL. If intolerable side effects develop, the dose will be reduced to the previously tolerated level or the medication will be discontinued if no tolerable therapeutic dose can be identified. Next, participants will complete a 1-week no-medication washout (range = 5-14 days allowed to accomodate participant schedules). Lastly, participants will complete a 3-week titration of Mixed Amphetamines (Dyanavel XR, 2.5mg/1mL). Doses will be increased at the end of each week using the following schedule: week 1 2mL; week 2 3mL; week 3 4mL. If intolerable side effects develop, the dose will be reduced to the previously tolerated level or the medication will be discontinued if no tolerable therapeutic dose can be identified.
Lek: methylphenidate HCl
3-week titration of liquid Quillivant XR
Lek: Mixed amphetamine salts extended release
3-week titration of liquid Dyanavel XR
Eksperymentalny: Mixed Amphetamines then Methylphenidate HCl
Participants in the second Arm will complete a 3-week titration of Mixed Amphetamines (Dyanavel XR, 2.5mg/1mL). Doses will be increased at the end of each week using the following schedule: week 1 2mL; week 2 3mL; week 3 4mL. If intolerable side effects develop, the dose will be reduced to the previously tolerated level or the medication will be discontinued if no tolerable therapeutic dose can be identified. Next, participants will complete a 1-week no-medication washout (range = 5-14 days allowed to accomodate participant schedules). Lastly, participants will complete a 3-week titration of Methylphenidate HCl (Quillivant XR, 25mg/5mL). Doses will be increased at the end of each week using the following schedule: week 1 2mL; week 2 4mL; week 3 6mL. If intolerable side effects develop, the dose will be reduced to the previously tolerated level or the medication will be discontinued if no tolerable therapeutic dose can be identified.
Lek: methylphenidate HCl
3-week titration of liquid Quillivant XR
Lek: Mixed amphetamine salts extended release
3-week titration of liquid Dyanavel XR

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Medication A Clinical Global Impressions - Improvement Scale (CGI-I)
Ramy czasowe: Week 3 Virtual Visit (Day 22)
Clinician rating of participant ADHD symptom improvement on medication A. The Clinical Global Impressions - Improvement Scale (CGI-I) is rated by a trained study clinician on a scale of 1-7, with scores of 1 ("very much improved") and 2 ("much improved") corresponding to clinically significant symptom improvement. Scores of 3-7 will indicate no improvement or worsening of symptoms.
Week 3 Virtual Visit (Day 22)
Medication B Clinical Global Impressions - Improvement Scale (CGI-I)
Ramy czasowe: End of Study Virtual Visit (Day 50)
Clinician rating of participant ADHD symptom improvement on medication B. The Clinical Global Impressions - Improvement Scale (CGI-I) is rated by a trained study clinician on a scale of 1-7, with scores of 1 ("very much improved") and 2 ("much improved") corresponding to clinically significant symptom improvement. Scores of 3-7 will indicate no improvement or worsening of symptoms.
End of Study Virtual Visit (Day 50)
Frontal Theta Beta Ratio
Ramy czasowe: Eligibility Visit (Day 0), Baseline Visit (Day 1), Crossover Visit (Day 29)
Theta-Beta Ratio (TBR): TBR will be calculated from periodic resting EEG. Periodic power isolates the oscillatory component of the EEG by subtracting the aperiodic power spectra from the total power. Periodic power is extracted with the Fitting Oscillations and One-Over-f (FOOOF) MATLAB toolbox which parametrizes resting state EEG data into aperiodic and periodic components. Resting spectral power values will be averaged over theta (4-6 Hz) and beta (13-30 Hz) frequencies across midline electrode clusters (frontal: Fz, F3, F4; central: Cz, C3, C4; parietal: Pz, P3, P4; occipital: Oz, O1, O2). Our primary analyses will focus on frontal TBR during the Lights-Off Resting condition.
Eligibility Visit (Day 0), Baseline Visit (Day 1), Crossover Visit (Day 29)
Aperiodic Dynamics
Ramy czasowe: Eligibility Visit (Day 0), Baseline Visit (Day 1), Crossover Visit (Day 29)
Aperiodic Dynamics: The aperiodic exponent for lights-off and lights-on resting conditions will be averaged across midline electrode clusters FOOOF MATLAB toolbox. Aperiodic dynamic values will be computed for each participant as the difference between lights-on and lights-off exponent, divided by the lights-off resting exponent, as in prior publications. Thus, higher scores will indicate greater exponents in the lights-on experiment. Primary analyses will use the central electrode cluster.
Eligibility Visit (Day 0), Baseline Visit (Day 1), Crossover Visit (Day 29)
P100 Visual Evoked Potential Amplitude
Ramy czasowe: Eligibility Visit (Day 0), Baseline Visit (Day 1), Crossover Visit (Day 29)
VEP P100 Amplitudes. The P100 VEP component will be derived from a passive pattern-reversal visual evoked potential (VEP) task that includes 200 500ms trials of a black and white checkerboard reversal over 3 minutes. P100 amplitudes will be averaged over an occipital electrode cluster (Oz, O1, O2) from approximately 75-150ms and extracted for each trial. Primary analyses will focus on mean VEP amplitude over trials.
Eligibility Visit (Day 0), Baseline Visit (Day 1), Crossover Visit (Day 29)
Vanderbilt Rating Scales
Ramy czasowe: Baseline, Medication A Week 1, Medication A Week 2, Medication A Week 3, Crossover Week 4, Medication B Week 5, Medication B Week 6, End of Study Week 7
The Vanderbilt Rating Scales include 18 items corresonding to DSM-5 ADHD symptoms. Parents and teachers will each complete the scales using an electronic form. Items are rated on a scale of 0-3, with 0 = symptom never or rarely occurs, and 3 = symptom often or almost always occurs. Total symptom severity is calculated as the sum of all 18 items; inattention symptom severity is calculated as the sum of items 1-9; hyperactivity/impulsivity symptom severity is calculated as the sum of items 10-18.
Baseline, Medication A Week 1, Medication A Week 2, Medication A Week 3, Crossover Week 4, Medication B Week 5, Medication B Week 6, End of Study Week 7

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
P100 Visual Evoked Potential Habituation
Ramy czasowe: Eligibility Visit (Day 0), Baseline Visit (Day 1), Crossover Visit (Day 29)
VEP P100 Amplitudes. The P100 VEP component will be derived from a passive pattern-reversal visual evoked potential (VEP) task that includes 200 500ms trials of a black and white checkerboard reversal over 3 minutes. P100 amplitudes will be averaged over an occipital electrode cluster (Oz, O1, O2) from approximately 75-150ms and extracted for each trial. Secondary analyses will focus on P100 amplitude changes over trial, i.e. habituation coefficients.
Eligibility Visit (Day 0), Baseline Visit (Day 1), Crossover Visit (Day 29)
Side Effects Rating Scale, Parent- and Teacher-Report
Ramy czasowe: Baseline, Medication A Week 1, Medication A Week 2, Medication A Week 3, Crossover Week 4, Medication B Week 5, Medication B Week 6, End of Study Week 7
Adverse effects associated with stimulant treatment will be recorded by parents and teachers on a weekly basis on the Vanderbilt Follow-Up rating scales, which include an adapted version of the Pittsburgh Side Effects Rating Scale. 12 side effects symptoms are rated on a scale of 0 = not currently a problem to 3 = severe problem. Side effects will be used for clinical decision making. Secondary exploratory analysis will examine associations between EEG features and total severity of side effects by summing ratings from the 12 items.
Baseline, Medication A Week 1, Medication A Week 2, Medication A Week 3, Crossover Week 4, Medication B Week 5, Medication B Week 6, End of Study Week 7
EEG Coherence
Ramy czasowe: Eligibility Visit (Day 0), Baseline Visit (Day 1), Crossover Visit (Day 29)
EEG coherence will be derived from resting state EEG as well as ERP tasks. Both global (i.e., long-range) and local (i.e., within region of interest) coherence will be examined in exploratory analyses.
Eligibility Visit (Day 0), Baseline Visit (Day 1), Crossover Visit (Day 29)
N2 Event Related Potential Amplitude
Ramy czasowe: Eligibility Visit (Day 0), Baseline Visit (Day 1), Crossover Visit (Day 29)
The HAPPE+ER pipeline will be used to extract N2 amplitudes during the Go-NoGo task, by condition and electrode. Mean amplitudes will be calculated for components across regions of interest, following visual inspection of temporal and topographic plots.
Eligibility Visit (Day 0), Baseline Visit (Day 1), Crossover Visit (Day 29)
P300 Event Related Potential Amplitude
Ramy czasowe: Eligibility Visit (Day 0), Baseline Visit (Day 1), Crossover Visit (Day 29)
The HAPPE+ER pipeline will be used to extract P300 amplitudes during the Go-NoGo task, by condition and electrode. Mean amplitudes will be calculated for components across regions of interest, following visual inspection of temporal and topographic plots.
Eligibility Visit (Day 0), Baseline Visit (Day 1), Crossover Visit (Day 29)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Boston Children's Hospital

Współpracownicy

Seattle Children's Hospital
Tris Pharma, Inc.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

15 września 2026

Zakończenie podstawowe (Szacowany)

30 maja 2031

Ukończenie studiów (Szacowany)

31 sierpnia 2031

Daty rejestracji na studia

Pierwszy przesłany

9 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

12 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

16 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

16 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

12 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • P00055002

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

All participants will be given the option to share their de-identified data with research or public registries at the time of informed consent. Data that includes video content (EEG .mff files; assessment videos) will not be shared for ethical reasons. Only de-identified data will be shared. Participants who do not consent to data sharing will still be eligible to participate in this study. All data projected during the study will be preserved by the PIs for the duration required by law in Massachusetts where the data are collected.

To facilitate interpretation of the data, relevant metadata, manual of operations, study protocols, and details regarding data collection tools will be shared and associated with relevant datasets.

Survey data, behavioral assessment scores, EEG and ERP measures will be made available in .csv or .txt format that do not require the use of specialized

Ramy czasowe udostępniania IPD

De-identified data will be uploaded to NDAR on an ongoing basis, per NIH requirements. Data can also be made available to individual researchers following publication, upon reasonable request.

Kryteria dostępu do udostępniania IPD

Data will be available to researchers through the NIH supported public database, NDAR, or by reasonable request to the PI.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Tak

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na ADHD

Badania kliniczne na methylphenidate HCl

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