NCT05912556已完成不适用
Brain Response to an Intervention Using Guided, At-Home Technology for the Mind - A Randomized, Controlled, Double-blinded, Parallel-group Intervention Study to Assess an At-Home Program for Improving Cognition and Inducing Changes in Brain Structure and Function
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 817
- 试验地点
- 1
- 主要终点
- Overall Composite from Creyos (formerly Cambridge Brain Sciences)
研究概览
简要总结
The objective of this study is to assess the effectiveness of two digital programs for providing mental stimulation, improving cognition, and inducing changes in brain structure and function.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects 25-80 years of age.
- •Ability to understand and speak English, follow written and verbal instructions (English), and give informed consent (English), as assessed by study staff.
- •Ability to comply with all the testing and study requirements, including the ability to independently use a video conferencing tool and the ability to independently use a computer to access the web.
- •Ability to independently complete a daily, online intervention and outcome assessments using a web browser compatible with the intervention and assessment software on a reliable, internet-connected laptop or desktop computer.
排除标准
- •Current, controlled (requiring treatment) or uncontrolled psychiatric diagnosis, including but not limited to posttraumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder, conduct disorder, attention-deficit/hyperactivity disorder, or other symptomatic manifestations that in the opinion of the Investigator may confound study data/assessments.
- •Current, controlled (requiring treatment) or uncontrolled neurological diagnosis, including but not limited to Alzheimer's Disease, other dementias, mild cognitive impairment, Huntington's Disease, Parkinson's Disease, multiple sclerosis, stroke, epilepsy, aphasia, or other condition that in the opinion of the Investigator may confound study data/assessments.
- •Any other medical condition in the last 90 days that in the opinion of the Investigator may confound study data/assessments.
- •Has been under the care of a caretaker or has not been living independently in the last 90 days.
- •In the last three years has used any of the following for more than two weeks continuously: Online courses, Online brain training programs
- •Known sensitivity (such as headaches, dizziness, nausea) to bright, stimulating video displays.
- •History of seizures (excluding febrile seizures), or significant motor or vocal tics, including but not limited to Tourette's Disorder and photo-sensitive epilepsy.
- •Visual acuity that cannot be corrected that prevents or negatively impacts computer activity.
- •Has participated in a clinical trial within 90 days prior to screening.
- •Pregnancy or planning to become pregnant.
- •Additional Exclusion Criteria for Cohort B only:
- •Unwillingness or inability to comply with imaging safety protocols.
- •Metal implants or exposure to shrapnel.
- •Left-handed or ambidextrous.
研究组 & 干预措施
Cohort A
Other
Remote-Only subjects
干预措施: Digital Program 1 (Device)
Cohort A
Other
Remote-Only subjects
干预措施: Digital Program 2 (Device)
Cohort B
Other
Remote + Imaging subjects
干预措施: Digital Program 1 (Device)
Cohort B
Other
Remote + Imaging subjects
干预措施: Digital Program 2 (Device)
结局指标
主要结局
Overall Composite from Creyos (formerly Cambridge Brain Sciences)
时间窗: Study Day 0 to Study Day 84
The Overall Composite is derived from the 12 tests in the Creyos battery.
次要结局
- Structural Brain Composite from Magnetic Resonance Imaging (MRI)(Study Day 0 to Study Day 84)
- Concentration Domain Score from Creyos(Study Day 0 to Study Day 84)
- Memory Domain Score from Creyos(Study Day 0 to Study Day 84)
- Reasoning Domain Score from Creyos(Study Day 0 to Study Day 84)
- White Matter Microstructure Composite from Diffusion Magnetic Resonance Imaging (dMRI)(Study Day 0 to Study Day 84)
- Within-Network Functional Connectivity from Resting-State functional Magnetic Resonance Imaging (fMRI)(Study Day 0 to Study Day 84)
- Planning Domain Score from Creyos(Study Day 0 to Study Day 84)
研究者
研究点 (1)
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