ADHDNCT07566468
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 of ADHD and Obsessive Compulsive Disorder (OCD), run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD, Obsessive Compulsive Disorder (OCD), Healthy Volunteer
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2026to 31 May 2029
- 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 10 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Ability to provide informed assent and parent consent
- Age: 10-17 years
- 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
- 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.
- Normal or corrected to normal vision
Who cannot join
- 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.
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, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Lindsay Oberman, Ph.D., 301-402-4193, lindsay.oberman@nih.gov
About this study
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.
Read more
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:
- 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:
- Evaluate the reliability of task performance on cognitive control tasks across sessions.
Exploratory Objectives:
- 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.
- 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.
- Compare the BOLD activity, and connectivity within and across "task-positive" function networks (TPNs) across ADHD, OCD, and HV groups.
- 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.
- 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:
- 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).
- Conditions
- ADHD, Obsessive Compulsive Disorder (OCD), Healthy Volunteer
- Keywords
- EEG, MRI, fMRI
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Retention for all visits of the study and task performance.
Withdrawal rates and Accuracy rates on task.
Measured: At each visit
Adverse Events reported related to study procedures
Patient Reported Negative Side Effects
Measured: At each visit
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
Measured: 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
Location of brain activation
Measured: At time of assessment
Secondary outcomes (1)
Accuracy and reaction time behavioral responses to cognitive control tasks.
Computerized Task performance
Measured: Across all study visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start30 Sep 2026
- Primary completion31 May 2029 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lindsay M Oberman, Ph.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07566468
- Sponsor's protocol ID
- 10002632
- Other IDs
- 002632-M
- Status last verified
- 28 Sep 2026
- First submitted
- 1 May 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No