Unravelling Dysfunctional Brain Networks in Patients With Parkinson's Disease Suffering From Presence Hallucination
试验速览
- 阶段
- 不适用
- 发起方
- Olaf Blanke
- 入组人数
- 10
- 试验地点
- 8
- 主要终点
- fMRI bold signal response during robotic manipulation
研究概览
简要总结
Investigation on how robotically mediated sensorimotor stimulation induces and triggers presence hallucinations in patients with Parkinson disease
详细描述
Parkinson's Disease (PD) is primarily known and characterized by motor symptoms such as tremor, rigidity and bradykinesia. However, a significant number of non-motor symptoms also accompany the unfolding of this disease. In fact, hallucinations are experienced by approximately 60% of the patients. The most common and amongst one of the earliest hallucinations in Parkinson's Disease, is the Presence Hallucination (PH), i.e., the strange sensation of perceiving someone behind when no one is actually there. In the present study the researchers aim at investigating the behavioural and neural mechanisms underlying symptomatic PH in PD. To do so the researchers intend to induce the PH in a repeated and controlled manner in the MRI scanner, with an extensively verified paradigm which gives rise to this sensation by means of robotically-mediated sensorimotor stimulation. This setup has in fact been shown to trigger the occurrence of symptomatic PH in these patients. The possibility to induce PH while the patient is in the MRI will allow the researchers to investigate online the brain networks associated with it.
With analysis on the fine brain connectivity changes during PH-induction, the investigators intend to pinpoint the exact mechanism behind the appearance of this hallucination in these patients, in a similar fashion to previous work with the PH-induction in healthy individuals.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Parkinson's disease
- •Able to understand instructions and provide informed consent.
- •Native speaking language of experimental site (or acquisition of language of experimental site before 6 years old).
- •Montreal Cognitive Assessment (Nasreddine & Patel, 2016) with score ≥
- •Able to manipulate the robotic device.
排除标准
- •Neurological comorbidities other than Parkinson's disease (e.g. Alzheimer's disease, vascular dementia, multiple sclerosis, stroke, traumatic brain injury, epilepsy, chronic migraine, etc.)
- •History or current condition of substance abuse and/or dependence (e.g., alcohol, drugs).
- •Suffering from or diagnosed with psychiatric illnesses according to DSM-V criteria (e.g., schizophrenia, bipolar disorders, autism, personality disorders, phobia etc.).
- •Family history (1st and 2nd degree) of psychiatric disorders (e.g., schizophrenia or bipolar disorders).
- •Severe somatic illnesses (e.g., cancer).
- •Severe tremors or physical disability preventing optimal use of robotic device.
- •Participating in a pharmacological study.
- •Local or general anaesthesia 30 days prior experiment
- •Inability to provide informed consent (legal guardianship)
- •The following are due to the MRI scanner: body weight exceeding 160kg, implanted metallic devices, foreign metallic objects, unstable angina, cardio-vascular diseases, tattoos with metallic components, external metallic objects, claustrophobia, pregnancy.
结局指标
主要结局
fMRI bold signal response during robotic manipulation
时间窗: Approximately 45 minutes during each participant's experimental session in arm 1
Analysis of changes of BOLD activity during the asynchronous condition as compared to the synchronous condition
Sensitivity to the induction bodily illusions of Presence Hallucination, Passivity experiences, loss of agency, and control questions, through lab-tailored questionnaires (7-point Likert-scale)
时间窗: Approximately 5 minutes at the end of each participant's experimental session in arm 1
Note that for the assessment of the sensitivity of each patient to the induction of the presence hallucination, passivity sensations, loss of agency, and control questions, the patients will perform two manipulations with the robotic system described in the introduction, in both the synchronous and asynchronous conditions
次要结局
未报告次要终点
研究者
Olaf Blanke
Professor Doctor
Ecole Polytechnique Fédérale de Lausanne