Investigation of Neurofeedback With Real-Time fMRI in Healthy Volunteers and Patients With Hyperkinetic Movement Disorders
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Phase 1 & 2: Difference in BOLD signal in a ROI during neurofeedback after training compared to resting baseline. Phase 3: Change in YGTSS measured prior to neurofeedback training compared to the score measured at a follow-up visit.
研究概览
简要总结
Background:
- Many people can learn to use feedback about brain activity to modify that activity, but is it not known if people with Tourette syndrome can modify their brain activity.
- Researchers have evidence that certain areas of the brain are involved in causing tics in people with Tourette syndrome. If people with Tourette syndrome can use feedback about brain activity to modify activity in those parts of the brain, they may be able to modify their brain activity to help control the tics.
Objectives:
- To determine if people with and without Tourette syndrome can learn to use thought to control brain activity.
- To test whether people who have Tourette syndrome can learn to control brain activities, possibly helping to control tics.
Eligibility:
- Healthy volunteers ages 18 and older who are right-handed and are willing to not consume caffeine or alcohol for 24 hours before the study visit.
- Patients with Tourette syndrome who have tics that can be observed and studied.
- All participants must be able to undergo magnetic resonance imaging (MRI) scans.
Design:
- Healthy volunteers (two visits to the NIH Clinical Center over a 2- to 4-week period; visit may last up to 3 hours):
- Screening visit, including physical examination and medical history, and a magnetic resonance imaging (MRI) scan if the individual has not had one performed at the National Institutes of Health in the past year.
- Study visit: Functional MRI (fMRI) scan to allow researchers to see if volunteers can learn to control their brain activity during a scan. Volunteers will be asked to complete tasks as directed during the fMRI scan.
- Patients with Tourette syndrome (three or four outpatient visits over a 4- to 6-week period; each visit may last up to 4 hours):
- Screening visit, including physical examination and medical history, and an MRI scan if the individual has not had one performed at the National Institutes of Health in the past year.
- Evaluation visit to ask questions about Tourette symptoms and to have patients complete questionnaires about their tics and their mental health.
- Study visit: fMRI scan to allow researchers to see if patients can learn to control their brain activity during a scan. Patients will be asked to complete tasks as directed during the fMRI scan.
- Final visit: Researchers will ask questions about tic symptoms, have patients complete questionnaires, and perform a brief exam. Afterward, patients will have an fMRI scan similar to the previous one.
- All participants will be paid a small amount of money in compensation for their participation in the study.
详细描述
Objective:
The objective of this study is to see if healthy volunteers and patients with hyperkinetic movement disorders such as Tic Disorders (TD) including Tourette Syndrome (TS) are able to learn how to alter their brain activity using feedback during functional magnetic resonance imaging (fMRI), and whether such feedback training can lead to improvement in symptoms in TD patients.
Study population:
This study is to be carried out in three phases. In Phase 1 we will study the feedback technique using fMRI with right-handed adult healthy volunteers, in Phase 2 we intend to study if adult patients with TD are also able to learn the feedback technique, and in Phase 3 we intend to study whether feedback training with fMRI leads to improvement in symptoms in TD patients and whether patients were able to retain the ability to alter their brain activity.
Design:
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Phase 1 & 2: Difference in BOLD signal in a ROI during neurofeedback after training compared to resting baseline. Phase 3: Change in YGTSS measured prior to neurofeedback training compared to the score measured at a follow-up visit.
次要结局
- Difference in BOLD signal in a ROI during neurofeedback compared to a resting baseline after subsequent scanning runs and during a transfer task, and in Phase 3 compared to controls. Also any changes of neurofeedback on various disease measures...
