NCT05351580已完成不适用
DiSCERN: Advanced PD Therapy Candidacy and Evaluation System - Advanced PD Data Collection
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Symptom severities
研究概览
简要总结
To collect data to develop models that identify when patients with advanced Parkinson's disease (PD) are not responding well to their current therapy and may be ready to consider advanced therapy and when patients receiving advanced therapy are not responding well and need a therapy adjustment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide informed consent
- •Diagnosed with Parkinson's disease
- •Current levodopa use
- •Hoehn and Yahr scale II-III
- •Ambulatory and capable of using the DiSCERN smartphone system
- •Able to understand and follow instructions regarding using the device
- •Half of participants (10 per site) identified as candidates for deep brain stimulation or drug pump by their treating neurologist, but before their surgeries take place.
- •The remainder (10 per site) will be individuals with advanced PD as defined by having a UPDRS motor complications scores ≥ 4.
排除标准
- •Any subject that does not meet the inclusion criteria will be excluded from this study. Subjects not capable of following the required clinical instruction for this study will be excluded. Potential subjects will be screened to ensure no cognitive impairments exist that would prohibit them from properly using the system. Exclusion criteria includes cognitive impairment as evidenced by a score less than 24 on the Montreal Cognitive Assessment (MoCA) UNLESS the subject has a caregiver able and willing to facilitate use of the DiSCERN system based on the judgement of the treating neurologist.
结局指标
主要结局
Symptom severities
时间窗: Eight (8) months compared to baseline
Symptom severities measured by smart watch
次要结局
- Unified Parkinson's Disease Rating Scale (UPDRS) Part III(Eight (8) months compared to baseline)
- MANAGE-PD questionnaire(Eight (8) months compared to baseline)
- Kinesia ONE motor assessment(Eight (8) months compared to baseline)
- Parkinson's Disease Questionnaire (PDQ-39)(Eight (8) months compared to baseline)
- Montreal Cognitive Assessment (MoCA)(Eight (8) months compared to baseline)
研究者
Dustin Heldman
Principal Investigator
Great Lakes NeuroTechnologies Inc.
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Real-PD Trial: Development of Clinical Prognostic Models for Parkinson's DiseaseParkinson's DiseaseNCT02474329Radboud University Medical Center304
已完成
不适用
Directional Deep Brain Stimulation With Patients With Advanced Parkinson's DiseaseParkinson DiseaseNCT05394688Hospital District of Helsinki and Uusimaa20
Enrolling By Invitation
不适用
Circuit-Based Deep Brain Stimulation for Parkinson's Disease; Udall Clinical CoreParkinson DiseaseNCT03021031University of Minnesota60
进行中（未招募）
不适用
The Personalized Parkinson Project (PPP)Parkinson DiseaseNCT03364894Radboud University Medical Center520
Unknown
不适用
Biomarker Analysis for GBA Associated Parkinson's DiseaseGaucher DiseaseParkinson DiseaseNCT03811496Lysosomal and Rare Disorders Research and Treatment Center, Inc.100