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Role of Theta Frequency Oscillations in Proactive and Reactive Control Processes in Youth With Attention Deficit Hyperactivity Disorder (ADHD) and Obsessive Compulsive Disorder (OCD)

17 settembre 2026 aggiornato da: National Institute of Mental Health (NIMH)

Background:

Attention deficit hyperactivity disorder (ADHD) is common in children. It can cause problems with attention and the ability to control actions and impulses. Obsessive compulsive disorder (OCD) is less common in children but not rare. It involves ongoing thoughts, urges, impulses, and repeated behaviors. Researchers want to study differences in brain activity between healthy children, those with ADHD, and those with OCD.

Objective:

To learn more about how the brain controls thinking and behavior.

Eligibility:

People aged 10 to 17 years with ADHD, OCD, or neither.

Design:

Participants will have 3 to 10 clinic visits in up to 1 year. Each visit will last 2 to 3 hours.

Three visits are required:

Behavioral. Participants will complete a computer task. Their mood, memory, attention, and thinking skills will be tested.

EEG. Participants will undergo electroencephalography (EEG) to measure signals in their brain. Small electrodes will be placed on the scalp. A cap will be stretched over the head. Signals will be recorded while participants rest or do tasks on a computer.

MRI. Participants will have a magnetic resonance imaging scan (MRI). They will lie on a table that rolls into a tube. The MRI will take pictures of their brain while they do tasks on a computer.

Seven more visits are optional. These include 2 more EEG visits and 2 more MRI visits.

Three will be magnetoencephalography (MEG) visits: MEG measures small magnetic field changes in the brain. A helmet with sensors will be placed on the head. Brain changes will be recorded while participants rest or do tasks on a computer.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Descrizione dettagliata

Study Description:

This is a pilot feasibility/tolerability study to evaluate the role of theta frequency oscillations in proactive and reactive control processes in youth with Attention Deficit Hyperactivity Disorder (ADHD) and Obsessive Compulsive Disorder (OCD). We hypothesize that: 1) Procedures will be tolerable for healthy volunteer (HV) children without a primary DSM-5 diagnosis, youth with ADHD and youth with OCD; 2) Procedures will be feasible for healthy volunteer (HV) children without a primary DSM-5 diagnosis, youth with ADHD and youth with OCD; 3) EEG and fMRI data for the majority of participants will be of sufficient quality for analysis (e.g. without artifact or excessive motion); 4) We will be able to identify cortical sources associated with resting-state and task-evoked theta oscillatory activity. This study will inform a future study where EEG-synchronized repetitive transcranial magnetic stimulation (rTMS) will modulate theta oscillations to improve cognitive control in youth with ADHD and youth with OCD.

Objectives:

Primary Objectives:

Evaluate the feasibility of MRI and EEG procedures at rest and during cognitive tasks in youth with ADHD, youth with OCD and HV youth.
Evaluate the tolerability of study procedures in youth with ADHD, youth with OCD and HV youth.
Evaluate the data quality obtained from the EEG and fMRI in youth with ADHD, youth with OCD and HV youth.
Identify cortical sources of resting-state and task-evoked theta oscillations in youth with ADHD, youth with OCD and HV youth.

Secondary Objectives:

1. Evaluate the reliability of task performance on cognitive control tasks across sessions.

Exploratory Objectives:

1. Compare the power of resting and task-evoked theta oscillations in the EEG recording across ADHD, OCD, and HV groups.

2a. Evaluate the relation between power in resting-state theta oscillations and task-evoked theta power in the electroencephalogram (EEG).

2b. Evaluate the relationship between power in resting-state theta oscillations in the EEG and task performance.

3. Evaluate the data quality and compare the power of resting and task-evoked theta oscillations in the MEG recording across ADHD, OCD, and HV groups.

4. Compare the BOLD activity, and connectivity within and across "task-positive" function networks (TPNs) across ADHD, OCD, and HV groups.

5. Compare the power of task-evoked EEG and MEG theta oscillations and cortical sources of task-evoked theta oscillations across standardized cognitive control and working memory tasks in youth with ADHD, youth with OCD and HV youth.

6. Develop latent executive functioning factors based on cognitive control and working memory task outcomes and evaluate the relationship between this latent factor and power of resting and task-evoked theta oscillations.

Endpoints:

Primary Endpoints:

Participant Retention for all visits of the study and task performance (Primary Objective 1).
Adverse Events reported related to study procedures (Primary Objective 2).
Percentage of EEG and fMRI data deemed to be of sufficient quality for analysis (e.g. without artifact or excessive motion) (Primary Objective 3).
Structural cortical region source localized from a combination of the EEG (and MEG in a subset of patients) and fMRI data (Primary Objective 4).

Secondary Endpoints:

1. Accuracy and reaction time behavioral responses to cognitive control tasks.

Exploratory Endpoints:

EEG Power in the theta frequency band (4-7Hz) (Exploratory Objective 1, 2a and 2b, and 5).
Power of MEG oscillations in the theta (4-7Hz) frequency band during rest and during cognitive control tasks (Exploratory Objective 3 and 5).
BOLD activation and connectivity in TPN networks (Exploratory Objective 4).
Structural cortical region source localized from a combination of the EEG (and MEG in a subset of patients) and fMRI data (Exploratory Objective 5).
Latent Inhibitory Control Factor and Latent Working Memory Factor derived by structural equation modeling using performance-based metrics across the three inhibitory control tasks and two working memory tasks (Exploratory Objective 6).

Tipo di studio

Osservativo

Iscrizione (Stimato)

110

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Nome: Lindsay M Oberman, Ph.D.
Numero di telefono: (301) 435-7962
Email: lindsay.oberman@nih.gov

Luoghi di studio

Stati Uniti
- Maryland
  - Bethesda, Maryland, Stati Uniti, 20892
    - National Institutes of Health Clinical Center
    - Contatto:
      
      Lindsay Oberman, Ph.D.
      
      Numero di telefono: 301-402-4193
      
      Email: lindsay.oberman@nih.gov

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Bambino

Accetta volontari sani

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

We aim to collect a sample of 90 youth ages 10-17, 30 with ADHD, 30 with OCD, and 30 age- and sex-matched typically developing healthy volunteer youth with complete data. In order to account for screen failures and participant attrition, we will recruit 110 individuals. Consistent with the sex differences in rates of psychopathology, we expect to enroll more males than females at an approximate 3:1 ratio in the ADHD group and 3:2 ratio in the OCD group, and therefore also more males than females in the sex-matched control group. Recruitment will be limited to DC, Maryland, and Virginia.

Descrizione

INCLUSION CRITERIA:
1. Ability to provide informed assent and parent consent
2. Age: 10-17 years
3. ADHD Group: Diagnosis of ADHD based on DSM-5 criteria
  OCD Group: Diagnosis of OCD based on DSM-5 criteria
  HV Group: No Neurological or Psychiatric diagnosis based on DSM-5 criteria
4. Wechsler Abbreviated Scale of Intelligence, Second Edition (WASI-II). WASI-II will be used as a measure of intellectual function. Children will be included when FSIQ > 70.
5. Normal or corrected to normal vision

EXCLUSION CRITERIA:

Participants will be screened to exclude participants in whom MRI or EEG might result in increased risk of side effects or complications or whose data would not be scientifically valid.

Non-English Speakers
Pregnancy
Any implant, prosthesis or alteration of the body that, in the opinion of the investigator, would be unsafe with MRI or EEG or that would produce an artifact that would compromise the integrity of data;
Active or History of psychosis, bipolar I disorder, Level 2 or 3 autism spectrum disorder, active severe substance use disorders (within the last month), have active suicidal intent or plan as detected on screening instruments;
Individuals currently taking stimulant medications who cannot tolerate being off their medication for up to 48 hours prior to the study visit and experience an exacerbation of symptoms that necessitates the resumption of medication prior to completion of the study visit.
Past or present medical or neurological condition, disease, disorder, genetic finding, or injury that, in the opinion of the Investigator, may significantly increase the potential risks of study participation, reduce or compromise a subject s ability to fully comply with all study requirements for the duration of the study or may compromise the integrity of the data.
For the HV group, any impairing current psychiatric diagnosis.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte Gruppo / Coorte Un gruppo o sottogruppo di partecipanti a uno studio osservazionale che viene valutato per gli esiti biomedici o sanitari.
Healthy Volunteer Youth Youth ages 10-17 without any Neurological or Psychiatric diagnosis based on DSM-5 criteria and Neuropsychological battery of tests.
Youth with Attention Deficit Hyperactivity Disorder Youth ages 10-17 with a DSM-5 Diagnosis of Attention Deficit Hyperactivity Disorder
Youth with Obsessive Compulsive Disorder Youth ages 10-17 with a DSM-5 Diagnosis of Obsessive Compulsive Disorder

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Participant Retention for all visits of the study and task performance. Lasso di tempo: At each visit	Withdrawal rates and Accuracy rates on task.	At each visit
Adverse Events reported related to study procedures Lasso di tempo: At each visit	Patient Reported Negative Side Effects	At each visit
Percentage of EEG and fMRI data deemed to be of sufficient quality for analysis (e.g. without artifact or excessive motion). Lasso di tempo: At time of assessment	Amount of analyzable data	At time of assessment
Structural cortical region source localized from a combination of the EEG (and MEG in a subset of patients) and fMRI data Lasso di tempo: At time of assessment	Location of brain activation	At time of assessment

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Accuracy and reaction time behavioral responses to cognitive control tasks. Lasso di tempo: Across all study visits	Computerized Task performance	Across all study visits

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

National Institute of Mental Health (NIMH)

Investigatori

Investigatore principale: Lindsay M Oberman, Ph.D., National Institute of Mental Health (NIMH)

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

NIH Clinical Center Detailed Web Page

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

23 settembre 2026

Completamento primario (Stimato)

31 maggio 2029

Completamento dello studio (Stimato)

31 maggio 2029

Date di iscrizione allo studio

Primo inviato

1 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

2 maggio 2026

Primo Inserito (Effettivo)

5 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 settembre 2026

Ultimo verificato

10 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

10002632
002632-M

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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .