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| ID | Type | Description | Link |
|---|---|---|---|
| 002632-M |
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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 12 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.
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:
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:
Secondary Endpoints:
1. Accuracy and reaction time behavioral responses to cognitive control tasks.
Exploratory Endpoints:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Participant Retention for all visits of the study and task performance. | Withdrawal rates and Accuracy rates on task. | At each visit |
| Adverse Events reported related to study procedures | 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). | 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 | Location of brain activation | At time of assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy and reaction time behavioral responses to cognitive control tasks. | Computerized Task performance | Across all study visits |
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INCLUSION CRITERIA
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
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.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lindsay M Oberman, Ph.D. | Contact | (301) 435-7962 | lindsay.oberman@nih.gov |
| Name | Affiliation | Role |
|---|---|---|
| Lindsay M Oberman, Ph.D. | National Institute of Mental Health (NIMH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
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| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D001008 | Anxiety Disorders |
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