Interactive Digital Technology (Project EVO) to Assess and Improve Cognitive Dysfunction in Patients With Systemic Lupus Erythematosus (SLE)
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Digit Symbol Substitution Scores
研究概览
简要总结
The purpose of this study is to evaluate whether a short interactive video game device is associated with performance on standard measures of attention and problem solving in patients with systemic lupus erythematosus(SLE). The study is also designed to see if playing the video game for four weeks improves attention and problem solving in patients with SLE.
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
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of SLE
排除标准
- •Major neurological problems (head trauma, degenerative vascular or metabolic disorder; neoplasm or toxic exposure) prior to SLE
- •Major psychiatric disorder prior to SLE
- •Major substance abuse
- •Major motor impairment
- •High SLE disease activity
- •History of learning disability
研究组 & 干预措施
Project EVO Multi- Treatment
Treatment group receives video game device treatment. Participant plays the game for 30 minutes a day, at least five days a week for four weeks.
干预措施: Project EVO Multi- Treatment (Device)
Control
No contact control
结局指标
主要结局
Change in Digit Symbol Substitution Scores
时间窗: 30 days
The participant scans a key and draws the correct symbol below a the corresponding number. Number of symbols drawn in 120 seconds is converted to a t-statistic using demographically corrected normative data.
Change in mean response time on EVO Monitor
时间窗: 30 Days
Average response time (ms) to in game stimuli
Change in response time variability on EVO Monitor
时间窗: 30 Days
Compares response time (ms) while single and multi- tasking in EVO game play
Change in EVO performance threshold
时间窗: 30 days
Calculation of performance when participant is single vs. multi-tasking
Change in Trail Making Test Scores
时间窗: 30 days
This is a test of visual attention and task switching. Scores are based on time to completion and number of errors made. Scores are converted to a t-score based on demographically corrected normative data.
Change in Stroop Test Scores
时间窗: 30 days
This examines cognitive flexibility. The participant reads color words or names ink colors from different pages as quickly as possible within a time limit. The test yields three scores based on the number of items completed on each of the three stimulus sheets as well as in interference score. Scores are converted to a t-statistic based on demographically corrected normative data.
Change in Digit Vigilance Test Scores
时间窗: 30 Days
This task measures attention. Scores are based on number of targets found and time to completion. Scores are converted to a t-score based on demographically corrected normative data.
次要结局
未报告次要终点