NL-OMON54196招募中2 期
Deep Brain Stimulation for MOtor symptoms in patients with Parkinson*s disease DEmentia (DBS- MODE) - DBS-MODE
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •age 18 years and older; • diagnosis of PD according to the clinical
- •diagnostic criteria of the Movement Disorder Society (MDS); • despite optimal
- •pharmacological treatment, at least one of the following symptoms, that are
- •severe enough to impair functioning in daily life independent of dementia: o
- •motor response fluctuations; o dyskinesia; o painful dystonia; o
- •levodopa-responsive bradykinesia; • diagnosis of probable or possible
- •Parkinson*s disease dementia (PDD) according to the MDS clinical diagnostic
- •criteria (a.o. this encompasses the development of dementia a*fter established
- •diagnosis of PD). This will be based on a standardized neuropsychological
- •examination; i.e. presence of at least 3 abnormal (i.e. < 2 standard
- •deviations) tests covering at least 2 cognitive domains. If a test cannot be
- •executed due to severe cognitive difficulties the test is regarded to be
- •abnormal; • an expected life expectancy of at least two years; • participant
- •has decision capacity to give informed consent, judgement of which is at the
- •discretion of an experienced neurologist from the study team; • participant
- •provides written informed consent; • regular contact with a caregiver, who has
- •approximately twice a week contact with the participant and also provides
- •written informed consent for their own participation.
排除标准
- •any neurodegenerative disorder other than PD;
- •previous neurosurgery for PD (e.g., DBS, pallidotomy, thalamotomy). Nota
- •bene: intrajejunal levodopa infusion or subcutaneous apomorphine infusion are
- •not considered an exclusion criterion;
- •contraindications for DBS-surgery, such as a physical disorder making surgery
- •Hoehn and Yahr stage 4 or 5 at the best moment during the day;
- •co*existence of another abnormality or disorder:
- •o that causes cognitive impairment that may improve with specific treatment; OR
- •o that besides PDD is judged to contribute significantly to the cognitive
- •impairment by the treating physician;
- •current major depressive episode according to the fifth edition of the
- •Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
- •current psychosis (treatment with antipsychotics is allowed);
- •other severely disabling condition;
- •immobility during the greater part of the day not related to off-drug phase
- •(e.g., due to apathy);
- •pregnancy, breastfeeding, and women of childbearing age not using a reliable
- •method of contraception.
研究者
相似试验
招募中
不适用
Deep brain stimulation for motor symptoms in patients with Parkinson’s disease dementiaParkinson's diseaseNL-OMON24650one44
已完成
2 期
Deep Brain Stimulation in Treatment-refractory patients with Major Depressive Disorder; A pilot studyclinical depressionMajor Depressive DisorderNL-OMON32776Academisch Medisch Centrum25
招募中
Unknown
Deep Brain Stimulation for Treatment-Refractory Obsessive-Compulsive Disorder: Understanding the Mechanism of Action.Mental Health - AnxietyObsessive-Compulsive DisorderACTRN12623000500651QIMR Berghofer Medical Research Institute5
招募中
不适用
Deep Brain Stimulation Therapy in Movement DisordersParkinson's DiseaseNCT02119611National Institute of Neurological Disorders and Stroke (NINDS)300
已完成
不适用
Deep Brain Stimulation in Treatment-refractory patients with Major Depressive Disorder.Major Depressive DisorderNL-OMON23670Academic Medical Center (AMC) Amsterdam, NL St Elizabeth Ziekenhuis Tilburg26