Impact of Stimulants and In-Scanner Motion on FMRI Neurofeedback and Task Performance in ADHD
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Neurofeedback mimicking the effects of stimulants
研究概览
简要总结
The goal of this interventional study is to learn the effects that stimulant medication prescribed to ADHD individuals has in their performance of attentive tasks, as measured by images and data collected through neuroimaging (fMRI) while also implementing new motion-correcting software. The main questions it aims to answer are:
- How do the use of stimulants affect brain activity and motion in fMRI research in ADHD studies?
- Can neurofeedback, an attentive task using real-time brain activity, engage the same brain circuits as seen with stimulant medication in individuals with ADHD?
Researchers will compare participant's brain activity from the completion of attentive tasks performed in the scanner while following their regular medication regimen and while abstaining to take medication. Researchers will also compare how the data collected using a more precise motion correction software differs to other previously reported data from ADHD studies who possibly employed more lenient measures of motion correction.
Participants will:
- Be asked to complete at least 4 fMRI sessions, two of which will include neurofeedback
- Be asked to abstain from taking stimulant medication on the day of two of these fMRI visits
- Complete attentive tasks while in the scanner that will activate target brain regions of interest
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12 or older
- •Able to follow verbal and written instructions in native language
- •Pre-existing clinical ADHD diagnosis (with or without comorbid anxiety diagnoses)
- •Pre-existing medication regimen of methylphenidate or amphetamine salt derivatives with no changes in the last month
排除标准
- •Known visual impairment preventing test administration
- •Contraindication of inability to participate in fMRI scanning (per MRI screening form)
- •Known, self-reported non-incidental structural brain abnormality
- •Autism Spectrum Disorder or Obsessive-Compulsive Disorder
- •Non-verbal
结局指标
主要结局
Neurofeedback mimicking the effects of stimulants
时间窗: Through data collection and analysis, an average of 1 year
Compare whether neurofeedback can mimic the effects of stimulants by engaging similar attentive brain circuits and providing a normalized activation effect similar to that of stimulants (measured in units of neural activation, with intensity based on p-value of significance, and by a z-score obtained in real-time during the task). This data will be collected during the completion of the neurofeeback task while in the scanner.
Performance on Attentive Tasks
时间窗: Through data collection and analysis, an average of 1 year
Performance on other attentive tasks (e.g., reaction time in seconds, accuracy of response), different from neurofeedback, will be observed while on stimulant medication, compared to performance on the same tasks while refraining from stimulant medication.
Precise motion correction as a better accountant of ADHD mechanisms
时间窗: Through data collection and analysis, an average of 1 year
Will compare results from data collected using fMRI and a new software that more precisely corrects for motion artifacts in a slice-by-slice manner to results previously reported for ADHD studies using more lenient fMRI motion artifact measures. Some of these comparisons will include more or less brain activation of the same regions, more precise windows of activation, etc.
次要结局
未报告次要终点
研究者
Alexander Cohen
Principal Investigator and Medical Physician
Boston Children's Hospital