NCT06716983招募中不适用
Multimodal Investigation of Cortico-Basal Ganglia-Thalamo-Cortical (CBGTC) Network Dynamics in Dystonic Patients With Deep Brain Stimulation (DBS)
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年12月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Local field potentials
研究概览
简要总结
The goal of this prospective open label study is to elucidate the pathophysiology of dystonia and to understand how deep brain stimulation (DBS) influences brain networks. The investigators will enroll patients with dystonia implanted with DBS of the Globus Pallidus internus (GPi) with sensing implantable neurostimulators, capable of measuring GPi local field potentials (LFPs).
The main questions it aims to answer are:
- does DBS influence pallidal LFPs in the long term?
- how the basal-ganglia-thalamo-cortical circuit is modified after DBS?
- do LFPs changes correlate with clinical improvement? Participants will undergo to serial clinical evaluations, magnetoencephalography (MEG) and functional Magnetic Resonance Imaging (fMRI) studies. Primarily, the data obtained from our study might help in clarifying basic pathological electrophysiological features of dystonia. These features might be secondarily used in future to provide a framework for an effective application of closed-loop DBS in Dystonia.
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 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with idiopathic or genetic dystonia who have already undergone DBS surgery of the globus pallidus internus
- •Patient implanted with a neurostimulator capable of chronically recording LFPs and which is fully compatible with magnetic fields up to 3 Tesla.
- •Age>12 years
排除标准
- •Evidence of CNS pathology or any other acquired conditions (perinatal, infective, toxic, neoplastic, vascular, psychogenic) responsible for the dystonia phenomenology,
- •Focal distribution of dystonia
- •Contraindications to brain MRI or EEG/MEG
- •Adult subjects unable to express consent to inclusion in the study
- •Pregnancy, and breastfeeding.
结局指标
主要结局
Local field potentials
时间窗: 1 year
To confirm the prominent pallidal low frequency oscillations in GPi (LFPs in alpha and theta bands) in dystonic patients and to evaluate the modifications in LFPs after DBS in the long term.
次要结局
- Coherence LFPs-MEG(1 year)
- Clinical correlations(1 year)
研究者
研究点 (1)
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