Impact of Brain Connectome and Personality on Cognitive Rehabilitation in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Impact of Conscientiousness on Cognitive Training Outcomes
研究概览
简要总结
This study aims to apply baseline MRI and neuropsychological measures to predict patient responses to behavioral cognitive rehabilitation. Training will take place over 12 weeks, 1 hour per day, 5 days per week.
The investigator hypothesizes the following:
[1a] The investigator expects that individuals with low baseline Conscientiousness will experience a lower magnitude of overall cognitive improvement following rehabilitation
- b] The investigator expects the impact of Conscientiousness on fidelity of rehabilitation will in part be moderated by individual differences in program adherence and executive function
- a] The investigator expects that individual differences in structural and functional connectome disturbances will in part explain differences in participant responses to cognitive rehabilitation.
This study will also serve to supplement the sample of participants for the current IRB approved study ((IRB: 603069, Title: A case-control, 5-year follow-up study of cardiovascular, environmental and genetic risk factors for disease progression in patients with multiple sclerosis.
详细描述
The participant will be asked to make a total of two (2) visits, approximately 90 days apart. Each visit will involve: neuro-performance testing, and self-report questionnaires. Each study visit is expected to take approximately 1-2 hours. Between the two visits, the participant will be asked to complete a 12 week, computer-based cognitive training program. This includes 1 hour of training each day for 5 days each week.
On Visit 1, the participants will undergo a full battery of neuro-performance tasks including tests and questionnaires that will measure their memory, thinking speed, fatigue, and personality. This visit is expected to take approximately 1-2 hours. The participants will be also asked to have a close friend or family member to complete similar surveys. A self-addressed envelope containing these questionnaires will be provided to take home with them. The participant will need to pass it onto a close friend or family member to be completed and mailed back.
In addition, the participant will be asked to take part in the 12 week computerized cognitive training program. This can be done at home, or anywhere the participant has access to a computer and internet. This cognitive training has been shown to improve cognitive performance in people with multiple sclerosis. The training involves a variety of interactive exercises which adapt to their abilities. The participants will need complete 1 hour of training each day, for 5 days each week.
At 90 days, the participant will return for the 1-2 hours' follow-up visit where they will complete the same cognitive testing and questionnaires which they had completed during visit 1.
All study visits will take place at Buffalo General Hospital. All of the procedures described above will be performed by a trained member of the research team as part of the research study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For all subjects:
- •males and females above age 18
- •fluent in English
- •education >9 years
- •Additional inclusion criteria for MS patients are as follows:
- •Clinically definite MS diagnosis
- •Expanded Disability Status Scale (EDSS) ≤ 6.5
- •MS patients must be relapse-free and stable from the time of their MRI acquired for the CEG-MS study
- •Willing and able to comply with the study procedures for the duration of the trial
排除标准
- •history of serious medical or psychiatric illness (other than MS in the patient group) that may affect cognitive functioning
- •color-blindness
- •history of developmental disability
- •past or current alcohol or substance dependence
- •History of major depressive disorder, bipolar disorder, or psychotic disorder predating the onset of MS
- •History of traumatic brain injury as defined by trauma causing loss of consciousness or transient post-traumatic or retrograde amnesia exceeding 5 min
- •Other pathology related to MRI abnormalities
研究组 & 干预措施
Cognitive Training
Individuals will take part in a computer-based cognitive training program. The program is aimed at building attention, processing speed, memory, and executive function.
干预措施: Cognitive Training (Behavioral)
结局指标
主要结局
Impact of Conscientiousness on Cognitive Training Outcomes
时间窗: This outcome will be measured according to changes from baseline cognition to follow-up measures, 12 weeks later (following cognitive rehabilitation)
The investigator expects baseline Conscientiousness to correlate positively with cognitive gains following rehabilitation. Conscientiousness will be measured using the NEO-Five Factor Inventory (NEOFFI). All scores for personality testing will be converted to age-corrected t-scores for final analysis. These are therefore standardized values without units.
Cognitive Training Outcomes
时间窗: This outcome will be measured according to changes from baseline cognition to follow-up measures, 12 weeks later (following cognitive rehabilitation)
Cognitive gains will be measured according to differences between baseline and followup testing for the following tests of cognition. * Brief Visuospatial Memory Test (BVMT). This is a test of visual and spatial learning and memory. * California Verbal Learning Test (CVLT). This is a test of verbal learning and memory. * Symbol Digit Modalities Test (SDMT). This is a test of visual information processing speed. All scores for cognitive testing will be converted to age-corrected t-scores for final analysis. These are therefore standardized values without units.
次要结局
- Moderating role of executive function(12 weeks, as above)
- Moderating role of program adherence(12 weeks, as above)
- Impact of baseline brain connectivity on cognitive rehabilitation outcomes(12 weeks, as above)
研究者
Ralph H.B. Benedict
Professor
State University of New York at Buffalo