Structural and Functional Networks in ALS: An Insight Into Pseudobulbar Affect
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Spectral connectivity
研究概览
简要总结
The investigators aim to elucidate characteristics of structural and functional brain connectivity in patients with amyotrophic lateral sclerosis (ALS) and pseudobulbar affect (PBA) using diffusion kurtosis imaging (DKI) and magnetoencephalography (MEG).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with ALS in the last 6 months according to Gold Coast Criteria
排除标准
- •- Lack of ability to answer survey through own ability or through a surrogate, for example by hand controlled, eye-controlled computer and/or tablet, or through telephone interview.
- •Lack of ability to cooperate.
- •Pregnancy
- •Drug addiction defined as the non-prescribed use of cannabis, opioids, or other narcotics.
- •Alcohol addiction defined as over 21 units weekly.
- •Lesional neurological diseases, such as stroke, tumor or multiple sclerosis
- •Neurodegenerative diseases other than ALS
- •Severe psychiatric disease such as major depression disorder, bipolar disease or schizophrenia
- •Contraindication for MRI and MEG scan according to hospital guidelines
- •Severe liver or kidney disease
- •Dysregulated heart disease
- •Ongoing treatment with any antidepressants or any antipsychotics at recruitment.
- •Diagnosed with frontotemporal dementia.
结局指标
主要结局
Spectral connectivity
时间窗: Baseline measurement and up to 6 month follow-up measurements
Estimation of connectivity (correlation between spikes of activity) between pseudobulbar affect afflilated cortical brain areas (prefrontal cortex, motor cortex, temporal lobe) derived through resting state magnetoencelphalography (MEG)
Mean kurtosis
时间窗: Baseline measurement and up to 6 month follow-up measurements
A measurement of kurtosis diffusion signal in pseudobulbar affect-affiliated brains areas (prefrontal lobe, pons, cerebellum, motor cortex, temporal lobe) derived from Diffusion kurtosis imaging (DKI)-MRI
次要结局
未报告次要终点
研究者
Christian Holm Steenkjær
Principal Investigator
Aalborg University Hospital