A Study to Assess the Feasibility of and to Characterize Project: EVO Monitor Cognitive Function Measurements When Played Daily, Weekly, or Multiple Times Per Day in Adults 40-55 Years Old
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 4
- 主要终点
- Feasibility of at-home use as measured by percent of completed assigned sessions
研究概览
简要总结
This is an open-label study in adults to assess at-home Project: EVO Monitor measurements over repeat play cycles. The study has three arms:playing multiple times per day, once daily, and once weekly for 4 to 8 weeks.
详细描述
This is an open-label study in adults ages 40 to 55 to assess Project: EVO Monitor measurements over repeat play cycles. The study has three arms: adults playing multiple times per day, adults playing once daily, and adults playing once weekly. The investigators plan to evaluate 76 participants (N = 30 in the daily and weekly arms, and N=16 in the multiple times per day arm) in two sites over a 4 to 8 week study period. The study period includes 2 in-clinic sessions and scheduled, at-home game play of the short (less than 7 minutes) Project: EVO Monitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 40-55 at the time of informed consent
- •Ability to follow written and verbal instructions (English).
- •Male and Female (Gender-matched).
- •Ability to comply with all the testing and requirements.
排除标准
- •Current, controlled (requiring a restricted medication) or uncontrolled, self-reported psychiatric diagnosis with significant symptoms such as post-traumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder, conduct disorder, attention deficit disorder, autism spectrum disorder, or other symptomatic manifestations that in the opinion of the Investigator that may confound study data/assessments.
- •Current self-reported community diagnosis of cognitive ailments such as dementia, Alzheimer's disease, stroke, traumatic brain injury, or other diseases that in the opinion of the Investigator that may confound study data/assessments.
- •Current diagnosis of severe learning disorder, dyslexia, or dyscalculia.
- •Current subjective complaints of inattention or memory loss.
- •Current use of psychotropic medication, prescription or otherwise.
- •Currently undergoing psychotherapy, behavioral therapy, or occupational therapy.
- •Motor condition that prevents game playing, as observed by investigator.
- •Impaired visual acuity, as defined by difficulty reading the informed consent even with corrective lenses.
- •Recent history (within the past 6 months) of suspected substance abuse or dependence.
- •History of seizures (exclusive of febrile seizures), a tic disorder, significant tics, a current diagnosis of Tourette's Disorder.
- •Taken part in a clinical trial within 30 days prior to screening.
- •Diagnosis of color blindness.
- •Regular use of psychoactive drugs that in the opinion of the Investigator may confound study data/assessments
- •Any other medical condition that in the opinion of the investigator may confound study data/assessments.
结局指标
主要结局
Feasibility of at-home use as measured by percent of completed assigned sessions
时间窗: 4 to 8 weeks
次要结局
未报告次要终点