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EEG Biomarkers for ADHD Stimulant Treatment

12. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

220

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Arzneimittel: methylphenidate HCl
3-week titration of liquid Quillivant XR
Arzneimittel: Mixed amphetamine salts extended release
3-week titration of liquid Dyanavel XR
Experimental: 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.
Arzneimittel: methylphenidate HCl
3-week titration of liquid Quillivant XR
Arzneimittel: Mixed amphetamine salts extended release
3-week titration of liquid Dyanavel XR

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Medication A Clinical Global Impressions - Improvement Scale (CGI-I)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
P100 Visual Evoked Potential Habituation
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Boston Children's Hospital

Mitarbeiter

Seattle Children's Hospital
Tris Pharma, Inc.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. September 2026

Primärer Abschluss (Geschätzt)

30. Mai 2031

Studienabschluss (Geschätzt)

31. August 2031

Studienanmeldedaten

Zuerst eingereicht

9. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. Juni 2026

Zuerst gepostet (Tatsächlich)

16. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • P00055002

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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

IPD-Sharing-Zeitrahmen

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.

IPD-Sharing-Zugriffskriterien

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

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Ja

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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