The Efficacy of a Remote Cognitive Remediation Therapy (CRT) Program on Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Pre-Intervention
研究概览
简要总结
Purpose/Goal: To determine if a remote computerized cognitive remediation program (CRT) can stabilize or improve cognitive functioning in a group of patients from the New York Institute of Technology Academic Health Care Center with Parkinson's disease (PD) after three months of intervention.
Hypothesis: Patients with PD who present with current cognitive deficits will show improvement in such deficits after three months of participation in a remotely supervised structured Cognitive Remediation Therapy Program (CRT) compared to control subjects with PD who receive treatment as usual.
Research design: Pilot study. Prospective randomized treatment and control comparison pre-post study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- 否
入选标准
- •Subjects must be currently enrolled in the Rock Steady Boxing Program at the Adele Smithers Parkinson's Disease Center.
- •Subjects must be between 40 and 85 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 have a MOCA score of 20 or above.
- •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 for 2 weeks prior to consent; in the judgment of the Investigator.
- •Subjects must have the visual, auditory, and motor capacity to use the intervention in the judgment of the Principal Investigator.
- •Subjects must be technologically capable of utilizing a computer and navigating through the programs.
- •Subjects must be mechanically capable of utilizing a computer and computer mouse.
排除标准
- •Subjects should not be participating in a concurrent research study or other interventional clinical trial 30 days prior to consenting.
- •Subjects should not have a history of mental retardation or pervasive developmental disorder; or other co-morbid neurological disorder (e.g., epilepsy.)
- •Subject is unable to physically use a computer or a computer mouse.
- •Subject is unable to or refuses to give consent.
研究组 & 干预措施
Parkinson's Disease Patients receiving Cognitive Remediation Therapy
Parkinson's Disease Subjects will undergo 10 weeks of Brain HQ training, 2 times a week an hour at a time. Also patients pre- and post-intervention RBANS and PDQ-39 scores.
干预措施: Cognitive Remediation Therapy Program (BrainHQ) (Other)
Parkinson's Disease Patients not receiving Cognitive Remediation Therapy
Parkinson's Disease Subjects will receive no intervention, but still undergo pre- and post-intervention RBANS and PDQ-39 scores.
结局指标
主要结局
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Pre-Intervention
时间窗: Initially, before any intervention/start of study.
A brief, individually administered test measuring attention, language, visuospatial/constructional abilities, and immediate and delayed memory.
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Post-Intervention
时间窗: 10 weeks after intervention/completion of the study.
A brief, individually administered test measuring attention, language, visuospatial/constructional abilities, and immediate and delayed memory.
Parkinson's Disease Questionnaire (PDQ-39) Pre-Intervention
时间窗: Initially, before any intervention/start of study.
A test that assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication.
Parkinson's Disease Questionnaire (PDQ-39) Post-Intervention
时间窗: 10 weeks after intervention/completion of the study.
A test that assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication.
Montreal Cognitive Assessment (MOCA) Pre-Intervention Screening
时间窗: Initially, before any intervention/start of study.
A rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.
次要结局
未报告次要终点