The "O-MEG-A-MIND" Study OPM- MEG in Non-immune And iMmune-medIated Neurological Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Detection of group differences over time in imaging metrics using OPM-MEG.
研究概览
简要总结
Over the past 20 years, doctors have gotten much better at spotting and treating brain conditions caused by the immune system attacking the body. These include illnesses like autoimmune encephalitis, ADEM, and multiple sclerosis. But even with better treatments, many patients-especially children-still struggle with long-term problems. Standard brain scans and tests often miss important issues like memory problems, emotional difficulties, trouble sleeping, and challenges with social behaviour. Early research using a special brain imaging technique (called MEG) has shown changes in brain networks that seem to be linked to poor memory. This study will use a new, advanced version of MEG that works even with very young children (as young as 2 years old). The goal is to better understand how these brain conditions affect children, compare them with other types of brain illness, and eventually use this technology to help predict outcomes and discover new ways to track brain health.
详细描述
This study is an 8-year cross-sectional and observational cohort study involving the use of OPM-MEG, MEG, MRI and neuropsychology testing based at the Aston Institute of Health and Neurodevelopment, Birmingham, UK. Children and young people with immune and non-immune mediated neurological disease aged 2-15 years will be recruited locally (Birmingham Children's Hospital) and from London and Manchester.
The longitudinal cohorts (n=25 in each, total n=50) will be those with immune- and non-immune mediated neurological disease within 9 months of diagnosis. They will be invited for 3 study visits (Study Visits 1, 2 and 3).
The cross-sectional cohort (n=25) will be those with immune-mediated neurological disease at least 18 months after diagnosis. They will be invited to for one study visit (Study Visit 1).
The study visits:
At Study Visit 1 (Baseline), participants will undergo OPM-MEG, MEG and MRI as well as neuropsychology testing and questionnaire completion. Total time taken is 5 hours. This visit can be split into 2 visits within a 2 week window.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals (age range 2 yrs to 16 years) who have received a diagnosis of immune-mediated neurological disease e.g. autoimmune encephalitis1, acute disseminated encephalomyelitis, multiple sclerosis. 2
- •Individuals who have received a diagnosis of a non-immune mediated neurological disease (age range 2 yrs to 15 years 11 months) e.g. stroke.
- •Patients who can give informed consent/ assent and have a person with parental responsibility capable of giving informed consent on their behalf if aged <16 years.
排除标准
- •There is metal in the body or any other contraindication that precludes MRI scanning at IHN, or child usually requires sedation for clinical MRI scans.
- •Participant dissents.
研究组 & 干预措施
Cross-sectional - participants who have had a neuroimmunological condition over 18 months ago
Longitudinal - participants who are within 9 months of disease
干预措施: OPM- Magnetoencephalography (Device)
结局指标
主要结局
Detection of group differences over time in imaging metrics using OPM-MEG.
时间窗: Baseline (Study Visit 1), 2 years (Study Visit 2), 5 years (Study Visit 3)
Change from Baseline in OPM-MEG Resting-State Delta-Band (1-4 Hz) Local Efficiency Local efficiency of resting-state brain networks derived from OPM-MEG recordings, computed from amplitude envelope correlation connectivity matrices (Desikan-Killiany atlas parcellation) using the Brain Connectivity Toolbox, compared between participants with immune-mediated and non-immune-mediated neurological disease across proportional connectivity thresholds (10-30%).
次要结局
- Change from Baseline in Whole-Brain Cortical Thickness(Baseline, 2 years, 5 years)
- Diagnostic/Predictive Performance of Imaging Metrics for Clinical Outcome Group (mRS-Defined)(2 years, 5 years)
- Correlation Between Resting-State Network Graph Measures and Wechsler Working Memory Index Score(Baseline, 2 years, 5 years)