Role of Theta Frequency Oscillations in Proactive and Reactive Control Processes in Youth With Attention Deficit Hyperactivity Disorder (ADHD) and Obsessive Compulsive Disorder (OCD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Participant Retention for all visits of the study and task performance.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 >
- •Normal or corrected to normal vision
排除标准
- •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
- •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.
研究组 & 干预措施
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
结局指标
主要结局
Participant Retention for all visits of the study and task performance.
时间窗: At each visit
Withdrawal rates and Accuracy rates on task.
Adverse Events reported related to study procedures
时间窗: At each visit
Patient Reported Negative Side Effects
Percentage of EEG and fMRI data deemed to be of sufficient quality for analysis (e.g. without artifact or excessive motion).
时间窗: At time of assessment
Amount of analyzable data
Structural cortical region source localized from a combination of the EEG (and MEG in a subset of patients) and fMRI data
时间窗: At time of assessment
Location of brain activation
次要结局
- Accuracy and reaction time behavioral responses to cognitive control tasks.(Across all study visits)