NCT01682668招募中不适用
Role of the Subthalamic Nucleus in the Control of Movement: Physiopathology of Akinesia in Parkinson's Disease.
Institut National de la Santé Et de la Recherche Médicale, France4 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2013年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 4
- 主要终点
- Firing rate of the subthalamic neurons
研究概览
简要总结
This program aims to understand the role of the subthalamic nucleus in the control of the movement in healthy humans and patients with Parkinson's disease, how the STN dysfunction contributes to akinesia and how the STN stimulation improves motor signs in PD patients .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for patients who will be operated
- •Diagnosis of idiopathic Parkinson's disease (according to the criteria of the United Kingdom Parkinson's Disease Society Brain Bank)
- •Age between 18 and 70;
- •Motor complications in the form of fluctuations in motor state or dyskinesias induced by dopaminergic therapy, despite medical treatment optimum;
- •Other medical conditions that are stable or do not interfere with the procedure proposed;
- •Excellent responsiveness to levodopa (UPDRS motor score improvement greater than 50% in the acute levodopa test)
- •Brain MRI without abnormality
- •Normality of biological examinations
- •Person who has voluntarily and informedly agreed to participate in the study (signature of a written consent)
- •Patient with social health insurance
- •Criteria for non-inclusion of Parkinsonian patients who will be operated
- •Contraindication to examinations necessary for inclusion
- •Evolutionary psychiatric pathology;
- •Dementia(MMS<24/30);
- •Patients with a medical condition that makes surgery dangerous neuro-surgical;
- •Bleeding-promoting diseases and laboratory test abnormalities clotting;
- •Existence of contraindications to MRI (cardiac or neural pacemaker, clips ferromagnetic surgeries, implants and metal objects, foreign bodies intraocular, pregnancy, claustrophobia).
- •Taking drugs interfering with coagulation for 1 month before intervention.
- •Persons under guardianship, curatorship or any other administrative or judicial measure deprivation of rights and liberty
- •Selection criteria for non-operated patients
- •Diagnosis of idiopathic Parkinson's disease (according to the criteria of the United Kingdom Parkinson's Disease Society Brain Bank);
- •Age between 18 and 70;
- •Other medical conditions that are stable or do not interfere with the proposed protocol;
- •Presence of axial signs (gait and/or balance disorders) no improved by antiparkinsonian treatment
- •Brain MRI without notable abnormality
- •Normality of biological examinations
- •Person who has voluntarily and informedly agreed to participate in the study (signature of a written consent)
- •Patient with social health insurance
- •Criteria for non-inclusion of non-operated patients
- •Contraindication to examinations necessary for inclusion
- •Progressive psychiatric pathology;
- •Dementia (MMS<24/30);
- •Existence of contraindications to MRI (cardiac or neural pacemaker, clips ferromagnetic surgeries, implants and metal objects, foreign bodies intraocular, pregnancy, claustrophobia).
- •Persons under guardianship, curatorship or any other administrative or judicial measuredeprivation of rights and liberty
- •Inclusion criteria for group 3 patients (already operated)
- •Diagnosis of idiopathic Parkinson's disease (according to the criteria of the United Kingdom Parkinson's Disease Society Brain Bank);
- •Bilateral deep brain stimulation of the subthalamic nucleus for more than 1 year
- •Age between 18 and 70;
- •Person who has voluntarily and informedly agreed to participate in the study (signature of a written consent)
- •Patient with social health insurance
- •Criteria for non-inclusion of Parkinsonian patients (already operated)
- •Contraindication to examinations necessary for inclusion
- •Evolutionary psychiatric pathology;
- •Dementia(MMS<24/30);
- •Persons under guardianship, curatorship or any other administrative or judicial measure deprivation of rights and liberty
- •Inclusion criteria for healthy subjects
- •Age between 18 and 70 years old
- •Normal neurological examination
- •Person who voluntarily and informedly agreed to participate in the study (signature of a written consent)
- •Patient with social health insurance
- 另有 4 项未显示
排除标准
- 未提供
研究组 & 干预措施
Frequency of subthalamic stimulation
Experimental
Comparison between healthy controls and PD patients (non-operable patients or who will be operated or already operated)
干预措施: Bilateral subthalamic stimulation (Procedure)
结局指标
主要结局
Firing rate of the subthalamic neurons
时间窗: During surgery for bilateral STN stimulation
Changes in the neuronal activity of the STN before, during and after the execution of an arm movement
次要结局
- Evoked related potentials of the STN(3-5 days after surgery for bilateral STN stimulation)
- Biomechanical parameters of gait initiation(6 months)
研究者
研究点 (4)
Loading locations...
相似试验
尚未招募
不适用
Subthalamic nucleus in cognitive control and inhibitioParkinson's diseaseNL-OMON33300Academisch Medisch Centrum20
Unknown
不适用
Changes of the Neuronal Activity in the Subthalamic Nucleus Under Remifentanil Sedation During Stereotactic Electrode ImplantationMovement DisordersEffect of RemifentanilNCT00588926Hadassah Medical Organization20
尚未招募
不适用
Role of the subthalamic nucleus for learning simple stimulus-response associations - a multi modal analysis using LFP and EEG dataG20Parkinson diseaseDRKS00020220Carl von Ossietzky Universität OldenburgFakultät VI - Medizin und GesundheitswissenschaftenDepartment für Humanmedizin5
Unknown
不适用
Mapping and Stimulating the Limbic Areas of the Subthalamic NucleusMapping the Limbic STN Using Neuronal ResponsesNCT01962194Hadassah Medical Organization10
Unknown
不适用
Sedation During Microelectrode Recordings Before Deep Brain Stimulation for Movement Disorders.Movement DisordersParkinsonian DisordersParkinson DiseaseDystoniaTourette SyndromeNCT00355927Hadassah Medical Organization20