Impact of Individual Cognitive Remediation for Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change of Test of Memory and Learning (TOMAL) score
研究概览
简要总结
This is an interventional clinical trial that will be conducted as a pilot project. Investigators hope to conduct the study to obtain at least 10 study completers.
The plan is to screen 20 Parkinson's Disease (PD) patients attending the Academic Health Care Center (AHCC) at NYIT College of Osteopathic Medicine clinic and enroll the eligible candidates based on the inclusion and exclusion criteria. Subjects will have 11 study visits over the 11-week period. Subjects cognition will be assessed using a paper-based Test of Memory and Learning (TOMAL) tool. The same tool will be used to asses and compare the cognition at baseline, and end study visits. The weekly 30-mins of cognitive remediation exercises will be done using the Brain. HQ cognitive remediation software.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be between 40 and 75 years old (including both ages) at the time of study screening.
- •Subjects must have a diagnosis of Parkinson's Disease by a physician.
- •Subjects must demonstrate adequate decisional capacity, in the judgment of the consenting study staff member, to make a choice about participating in this research study.
- •Subjects must have been clinically stable (non-acute) for 2 weeks prior to consent; in the judgment of the Investigator.
- •Subjects with a cognition level between Impaired and Average (scaled score between 4-12 or Index Score between 70-110) based on TOMAL Cognitive assessment at Visit 1
- •Subjects must have the visual, auditory, and motor capacity to use the intervention in the judgment of the Principal Investigator.
排除标准
- •Subjects who are participating in a concurrent research study or another interventional clinical trial 30 days prior to consenting.
- •Subjects having a history of mental retardation or pervasive developmental disorder; or other co-morbid neurological disorder (e.g., epilepsy.)
- •Subjects who appear to be intoxicated or under the influence of a controlled substance on any day of assessment must be rescheduled and may be discontinued based upon the discretion of the investigator
- •Subjects on medications that affect the cognition in the last 12 hours prior to the study visits that assess the cognitive functions
研究组 & 干预措施
Parkinson's disease patients with cognitive impairment
Online cognitive remediation program.
干预措施: Cognitive Remediation (Behavioral)
结局指标
主要结局
Change of Test of Memory and Learning (TOMAL) score
时间窗: Baseline and 11 weeks
Paper based memory and attention test administered at the beginning and end of the study
次要结局
未报告次要终点