ClinicalTrials.gg
RecruitingNCT07566468Updated Oct 5, 2026

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

An observational study in ADHD, Obsessive Compulsive Disorder (OCD) and Healthy Volunteer, sponsored by National Institute of Mental Health (NIMH). Recruiting at 1 site in United States. Open to participants aged 10 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by National Institute of Mental Health (NIMH) · Observational

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Oct 5, 2026Start date movedGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
110
Ages
10 Years to 17 Years
Sex
All
01

Study summary

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.

Read the detailed description

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:

  1. Evaluate the feasibility of MRI and EEG procedures at rest and during cognitive tasks in youth with ADHD, youth with OCD and HV youth.
  2. Evaluate the tolerability of study procedures in youth with ADHD, youth with OCD and HV youth.
  3. Evaluate the data quality obtained from the EEG and fMRI in youth with ADHD, youth with OCD and HV youth.
  4. 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:

  1. Participant Retention for all visits of the study and task performance (Primary Objective 1).
  2. Adverse Events reported related to study procedures (Primary Objective 2).
  3. Percentage of EEG and fMRI data deemed to be of sufficient quality for analysis (e.g. without artifact or excessive motion) (Primary Objective 3).
  4. 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:

  1. EEG Power in the theta frequency band (4-7Hz) (Exploratory Objective 1, 2a and 2b, and 5).
  2. Power of MEG oscillations in the theta (4-7Hz) frequency band during rest and during cognitive control tasks (Exploratory Objective 3 and 5).
  3. BOLD activation and connectivity in TPN networks (Exploratory Objective 4).
  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).
  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).
02

Conditions studied

  • ADHD
  • Obsessive Compulsive Disorder (OCD)
  • Healthy Volunteer

Keywords

  • EEG
  • MRI
  • fMRI
03

In context

Attention Deficit Disorder with Hyperactivity

1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.

This study's planned enrollment of 110 is below the median of 127 across 329 observational studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

National Institute of Mental Health (NIMH) is the lead sponsor of 367 studies on the registry; 45 are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 24 (96%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Ability to provide informed assent and parent consent

    1. Age: 10-17 years
    2. ADHD Group: Diagnosis of ADHD based on criteria

      OCD Group: Diagnosis of OCD based on DSM-5 criteria

      HV Group: No Neurological or Psychiatric diagnosis based on DSM-5 criteria

    3. 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.
    4. Normal or corrected to normal vision

Exclusion criteria

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.

  1. Non-English Speakers
  2. Pregnancy
  3. 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;
  4. 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;
  5. 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.
  6. 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.
  7. For the HV group, any impairing current psychiatric diagnosis.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
110 participants (estimated)

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Participant Retention for all visits of the study and task performance.

    Withdrawal rates and Accuracy rates on task.

    Time frame: At each visit

  2. Adverse Events reported related to study procedures

    Patient Reported Negative Side Effects

    Time frame: At each visit

  3. Percentage of EEG and fMRI data deemed to be of sufficient quality for analysis (e.g. without artifact or excessive motion).

    Amount of analyzable data

    Time frame: At time of assessment

  4. Structural cortical region source localized from a combination of the EEG (and MEG in a subset of patients) and fMRI data

    Location of brain activation

    Time frame: At time of assessment

Secondary outcomes

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

    Computerized Task performance

    Time frame: Across all study visits

07

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for May 2029, 32 months after the start.

Of 85 non-industry observational studies under Attention Deficit Disorder with Hyperactivity, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 69. This study's planned 32 months is close to that.

Counting every sponsor, half of 95 studies reached it within 35 months; a quarter within 20 and three quarters within 69.

How these figures are worked out, and which studies are left out of them.

Registered
May 1, 2026
First posted
May 5, 2026
StartActual
Sep 30, 2026
Primary completionEst.
May 31, 2029
CompletionEst.
May 31, 2029
Last update
Oct 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Sep 17, 2026→Sep 30, 2026
Oct 5, 2026
Show all 2 updates
  1. Oct 5, 2026
    Start date Sep 17, 2026→Sep 30, 2026
  2. Sep 30, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07566468
Responsible party
Sponsor
First posted
May 5, 2026
Start date
Sep 30, 2026
Primary completion
May 31, 2029 (estimated)
Completion
May 31, 2029 (estimated)
Last update
Oct 5, 2026

Study contacts

Lindsay M Oberman, Ph.D.
Contact
lindsay.oberman@nih.gov
(301) 435-7962
Lindsay M Oberman, Ph.D.
principal investigator · National Institute of Mental Health (NIMH)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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