NCT04677621撤回不适用
Telemedicine Nurse DBS for Parkinson's Disease: The TEND Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- The number of participant clinic visits
研究概览
简要总结
The central hypothesis is that home health nurses can improve access and provide high quality care when guided by a sophisticated platform that integrates bioinformatics, patient-specific computational modeling, and continuous symptom measurement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre-operative Inclusion Criteria: A good response to levodopa is required in order to exclude patients with Parkinson's plus syndromes, and will be defined as a 30% improvement in parkinsonian motor signs based upon the Unified PD Rating Scale (UPDRS) motor examination subscore, following the administration of 1.5 times the typical dopaminergic dose during the screening neurological examination. Patients must also have PD for a minimum of 5 years duration.
- •Additional inclusion criteria consist of: 1) Hoehn & Yahr stage II or worse when off; 2) Intractable, disabling motor fluctuations and/or tremor; 3) Age between 30-75 years; 4) Unsatisfactory clinical response to maximal medical management (with trials of both higher and lower doses of antiparkinsonian drugs). 5) A stable/optimal medical regimen of antiparkinsonian drug therapy for at least one month prior to surgery; 6) access to high-speed internet in the home.
排除标准
- •Clinically significant medical disease that would increase the risk of developing pre- or postoperative complications (e.g. significant cardiac or pulmonary disease, uncontrolled hypertension).
- •Evidence of secondary or atypical parkinsonism.
- •MRI scan with significant evidence of brain atrophy or other abnormalities.
- •Dementia as evidenced by impairment in two neuropsychological domains and impaired or borderline neuropsychological function in one additional domain.
- •A major untreated psychiatric disorder.
结局指标
主要结局
The number of participant clinic visits
时间窗: 6 MONTHS from date of enrollment
The number of in-person clinic visits required for each participant during the 6-month post operative DBS period.
次要结局
- PDQ-39 Scores(6-months)
研究者
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