Piloting a Novel, Mobile Cognitive Tracking and Training Tool for Patients With Parkinson's Disease (PD)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change scores for depressive symptoms using Beck Depression Scale (BDI-II)
研究概览
简要总结
The overall goal of this research proposal is to develop an adjunct to standard treatments that 'correct' disrupted neural circuitry in Parkinson's Disease (PD) patients. Directly treating these core deficits via targeted behavioral training should slow the progression of PD, assure greater resilience against future decline, and improve the quality of life of many living with PD. The purpose of this exploratory research study is to determine the benefits, if any, of the mobile device-based treatment described above in individuals with PD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must meet diagnostic criteria for Parkinson's Disease with mild-to-moderate stage
- •Participants must be fluent English speakers
- •Participants must have the capability of completing the study as assessed by intact global cognition
- •Participants must be able to engage with computerized cognitive tasks as required in the study
- •Participants must have normal vision (or corrected to normal vision)
- •Participants must have adequate hearing acuity
- •Participants must have the motor capacity to use an iPad or mobile device
- •Participants must be willing to commit to the time requirements of the study
- •Participants must obtain benefit on dopaminergic treatment (dopamine agonist or levodopa) and be on a stable dose for at least one month prior to screening
- •Participant must have access to wireless internet connectivity
- •Participant must have at least mild depression as assessed by Beck Depression Inventory (BDI-II)
排除标准
- •Participants who are unable to perform neuropsychological assessments in the opinion of the evaluating staff person
- •Participants who cannot comprehend or follow instructions, in the opinion of the consenting staff person
- •Participants who are not capable of giving informed consent, in the opinion of the consenting staff person
- •Participants who show signs of intoxication due to current substance abuse (including alcohol and/or illegal drugs) during any in person visit
- •Participants with history of significant medical diseases or multiple neurological events of the head
- •Participants with serious or unstable medical illness
- •Participants with history or current diagnosis of the following Diagnostic and Statistical Manual of Mental Disorders (DSM-5) psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorder not otherwise specific, bipolar disorder, substance dependence, substance abuse (< 1 year) (subjects with co-occurring post-traumatic stress disorder and related disorders are eligible for participation) as diagnosed through medical history
- •Participants with history of seizure disorder
- •Participants who are pregnant
- •Participants who experience frequent falls (several times a week)
- •Participants with severe dyskinesia
- •Participants with active suicidal ideations or behaviors as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
- •Participants enrolled in a concurrent clinical trial involving an investigational pharmaceutical, nutraceutical, medical device, or behavioral treatment that could affect the outcome of this study
- •Participant is using computer-based cognitive training programs or has used it within a month of the consent date
研究组 & 干预措施
Experimental Treatment
Computerized plasticity-based adaptive cognitive training requiring up to a maximum of 80 treatment sessions, up to 7 sessions per week, 15-60 minutes per session
干预措施: Computerized Plasticity-based Adaptive Cognitive Training (Other)
Active Comparator
Commercially available computerized training requiring up to a maximum of 80 treatment sessions, up to 7 sessions per week, 15-60 minutes per session.
干预措施: Commercially available computerized training (Other)
结局指标
主要结局
Change scores for depressive symptoms using Beck Depression Scale (BDI-II)
时间窗: At 3 months and 6 months
Change scores for Quality of Life using Parkinson's Disease Questionnaire (PDQ-39)
时间窗: At 3 months and 6 months
次要结局
未报告次要终点