Unravelling Dysfunctional Brain Networks in Patients With Parkinson's Disease Suffering From Hallucinations
试验速览
- 阶段
- 不适用
- 发起方
- Olaf Blanke
- 入组人数
- 40
- 试验地点
- 12
- 主要终点
- 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)
研究概览
简要总结
Investigation on how robotically mediated sensorimotor stimulation induces and triggers presence hallucinations in different clinical groups of parkinsonian patients, and in aged-matched controls
详细描述
Parkinson's Disease (PD) is a condition mostly known and characterized by motor symptoms, such as tremors, rigidity, bradykinesia, amongst others. Yet, recent bodies of research have identified a significant number of non-motor symptoms that also accompany the unfolding of this disease. These non-motor symptoms mainly focus on hallucinations that will develop with the course of the disease, and will affect approximately 50% of the patients suffering from Parkinson's. This number rises to 70% if minor hallucinations, mild phenomena and poorly-structured hallucinations, are included. Despite the potential impact in the patients' lives, and previous efforts to study these phenomena, the brain changes that underly hallucinations in PD are still poorly understood. With the current study the investigators aim to improve this understanding, by studying the most common minor hallucination in Parkinson's Disease, the Presence Hallucination (PH), which can be defined as the strange sensation of perceiving someone behind when no one is actually there. To study it in a controlled manner, the investigators will induce this hallucination with an extensively verified paradigm, which gives rise to this sensation through robotically-mediated sensorimotor stimulation, in both healthy individuals, and PD patients. The researchers intend to discern the sensitivity of different groups of PD patients to the induction of this hallucination, by targeting PD patients, with hallucinations including PH, with hallucinations but without PH, without any hallucinations, and an aged match control group with no neurological comorbidities. The investigators intended to extend previous work on the induction of the PH in PD patients, by identifying the neural correlates of this induction in these patients, in a similar fashion to previous work in healthy individuals. Moreover, the researchers also intend to extend the general understanding of the basis for hallucinations in PD by extending what was done in previous work, to more stratified cohorts of PD patients, that will not only be analysed in terms of static during rest, but also in terms of dynamic connectivity, and will also perform the PH-inducing task in the scanner, as mentioned before.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Diagnosed with Parkinson's disease (expect for healthy controls)
- •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
- •For PD patients only: Neurological comorbidities other than Parkinson's disease (e.g. Alzheimer's disease, vascular dementia, multiple sclerosis, stroke, traumatic brain injury, epilepsy, chronic migraine, etc.)
- •For healthy controls only: Parkinson's disease or other neurological illnesses
- •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)
- •For the MRI part only: body weight exceeding 160kg, implanted metallic devices, implant for deep brain stimulation, 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
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: 5 minutes, at the end of each participant's session in arm 2
Note that for the measuring 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
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) in the MRI scanner
时间窗: 5 minutes, at the end of each participant's session in arm 4
After the sensorimotor task in the MRI scanner that induces the presence hallucination, ratings for the strength of the perceived sense of presence and associated phenomena are collected with the participants
fMRI blood-oxygen level dependent signal response during resting state
时间窗: Approximately 30 minutes, during arm 3
We will analyse resting state data from the different populations of PD patients in this study and healthy controls
fMRI blood-oxygen level dependent signal during robotic stimulation
时间窗: Approximately 45 minutes, during arm 4
We will analyse neural data from PH-induction inside the scanner, from the different populations of PD patients in this study and healthy controls
次要结局
- Dosage of dopaminergic medication (in daily equivalent mg/day)(Approximately 10 minutes during screening)
- Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)(15 minutes during arm 1)
- Scale for the Assessment of Positive Symptoms (SAPS)(15 minutes during arm 1)
- Hallucination questionnaire specific for PD(15 minutes during arm 1)
- Questionnaire for Impulsive-compulsive Disorders in Parkinson's Disease (QUIP)(5 minutes during arm 1)
- The Hospital Anxiety and Depression Scale (HADS)(5 minutes during arm 1)
- REM Sleep Behaviour Disorder Screening Questionnaire (RBDSQ)(5 minutes during arm 1)
- Dimensional Apathy Scale (DAS)(5 minutes during arm 1)
- Semantic and phonemic verbal fluency(4 minutes during arm 1)
- Modified 5-point test (non-verbal fluency)(3 minutes during arm 1)
- Beck Cognitive Insight Scale (BCIS)(3 minutes during arm 1)
- UCLA loneliness questionnaire(2 minutes during arm 1)
- Neuropsychiatric Fluctuations Scale for Parkinson's Disease (NPS)(5 minutes during arm 1)
- Parkinson's disease - Cognitive Rating Scale (PD-CRS)(25 minutes during arm 1)
- Trail Making Test A and B (TMT A; TMT B)(maximum of 3 minutes during arm 1)
- Symbol search(2 minutes during arm 1)
研究者
Olaf Blanke
Professor Doctor
Ecole Polytechnique Fédérale de Lausanne