Network Characteristics in Essential Tremor (ET) Patients Undergoing High-Intensity Focused Ultrasound (HiFU): a Magnetoencephalography (MEG) Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in brain electrical activity measured by magnetoencephalography (MEG) before and after treatment with focused ultrasound
研究概览
简要总结
The purpose of this research is to learn more about how the brain works in people with essential tremor, and how it changes after treatment with High-Intensity Focused Ultrasound (HiFU). Essential tremor is a movement disorder that causes shaking, usually in the hands, and can make everyday tasks difficult. HiFU is a treatment that uses focused sound waves to target a small area in the brain involved in tremor. In this study, the investigators aim to understand how this treatment affects the brain's networks by using safe, non-invasive tests such as brain imaging, brain wave recordings, and movement assessments.
详细描述
Participation in this study will last for approximately eight months. Participants will be asked to attend a total of six study visits. These include a screening visit to see if a potential participant qualifies for the study, an assessment visit before treatment and treatment visits. Prior to and after treatment (one day, six weeks, and six months after treatment), participants will have Magnetoencephalography (MEG), Functional Magnetic Resonance Imaging (fMRI), Sensor-Based Gait and Motor Function Assessments and Self-Report Questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >50 years and <85 years
- •Refractory to at least 2 first line tremor medications
- •Skull Density Ratio (SDR) > = 0.35
排除标准
- •MR/MEG incompatible implants and implantable devices (ex: pacemaker)
- •Head tremor interfering with MEG recording
- •Severe depression and/or anxiety
- •Severe cognitive impairment
研究组 & 干预措施
Essential Tremor refractory to at least 2 first line tremor medications
Eligible patients will have MRI and fMRI scans, MEG recordings, sensor-based motor assessments, clinical evaluations and questionnaires and rating scales before the treatment, right after, and again at 6 weeks and 6 months afterward.
干预措施: MEG (Diagnostic Test)
Essential Tremor refractory to at least 2 first line tremor medications
Eligible patients will have MRI and fMRI scans, MEG recordings, sensor-based motor assessments, clinical evaluations and questionnaires and rating scales before the treatment, right after, and again at 6 weeks and 6 months afterward.
干预措施: Sensor-based motor assessments (Diagnostic Test)
Essential Tremor refractory to at least 2 first line tremor medications
Eligible patients will have MRI and fMRI scans, MEG recordings, sensor-based motor assessments, clinical evaluations and questionnaires and rating scales before the treatment, right after, and again at 6 weeks and 6 months afterward.
干预措施: Clinical evaluations (Other)
Essential Tremor refractory to at least 2 first line tremor medications
Eligible patients will have MRI and fMRI scans, MEG recordings, sensor-based motor assessments, clinical evaluations and questionnaires and rating scales before the treatment, right after, and again at 6 weeks and 6 months afterward.
干预措施: Questionnaires and rating scales that (Other)
Essential Tremor refractory to at least 2 first line tremor medications
Eligible patients will have MRI and fMRI scans, MEG recordings, sensor-based motor assessments, clinical evaluations and questionnaires and rating scales before the treatment, right after, and again at 6 weeks and 6 months afterward.
干预措施: MRI and fMRI scans (Diagnostic Test)
结局指标
主要结局
Change in brain electrical activity measured by magnetoencephalography (MEG) before and after treatment with focused ultrasound
时间窗: baseline to 7 months
Brain electrical activity will be recorded using magnetoencephalography (MEG) before treatment and at follow-up visits after treatment. MEG signals are collected as time-series data and processed to derive quantitative measures of functional brain connectivity that inform how interconnected different brain regions are. The primary outcome is the average change in these connectivity measures from pre-treatment baseline to post-treatment follow-up across participants.
次要结局
- Correlation between change in tremor amplitude and change in MEG connectivity(Baseline (pre-treatment) to 6 months post-treatment)
- Correlation between change in tremor frequency and change in MEG connectivity(Baseline (pre-treatment) to 6 months post-treatment)
- Correlation between change in gait parameters and change in MEG connectivity(Baseline (pre-treatment) to 6 months post-treatment)
- Correlation between change in postural sway and change in MEG connectivity(Baseline (pre-treatment) to 6 months post-treatment)
- Correlation between change in 360-degree turn performance and change in MEG connectivity(Baseline (pre-treatment) to 6 months post-treatment)
- Change from Baseline in MEG-derived Functional Connectivity Strength(Baseline (pre-treatment) to 6 months post-treatment)
- Change from Baseline in MEG-derived Directed Connectivity(Baseline (pre-treatment) to 6 months post-treatment)
- Change from Baseline in MEG-derived Oscillatory Band Power(Baseline (pre-treatment) to 6 months post-treatment)
- Change from Baseline in MEG-derived Network Coherence(Baseline (pre-treatment) to 6 months post-treatment)
- Correlation between sonication energy and MEG connectivity(Baseline (pre-treatment) to 6 months post-treatment)
- Baseline (pre-treatment) to 6 months post-treatment(Baseline (pre-treatment) to 6 months post-treatment)
- Correlation between number of sonications and MEG connectivity(Baseline (pre-treatment) to 6 months post-treatment)
- Correlation between lesion volume and MEG connectivity(Baseline (pre-treatment) to 6 months post-treatment)
- Correlation between patient age and MEG connectivity(Baseline (pre-treatment) to 6 months post-treatment)
- Correlation between disease duration and MEG connectivity(Baseline (pre-treatment) to 6 months post-treatment)
- Correlation between change from baseline in CRST score and MEG connectivity(Baseline (pre-treatment) to 6 months post-treatment)
- Correlation between change from baseline in tremor amplitude and MEG connectivity(Baseline (pre-treatment) to 6 months post-treatment)
- Correlation between change from baseline in tremor frequency and MEG connectivity(Baseline (pre-treatment) to 6 months post-treatment)
- Correlation between change from baseline in gait speed and MEG connectivity(Baseline (pre-treatment) to 6 months post-treatment)
- Correlation between change from baseline in postural sway and MEG connectivity(Baseline (pre-treatment) to 6 months post-treatment)
- Correlation between change from baseline in 360-degree turn performance and MEG-derived functional connectivity strength.(Baseline (pre-treatment) to 6 months post-treatment)