跳至主要内容
临床试验/NCT06376175
NCT06376175已完成不适用

Task Atlas: An Observational Study to Develop a Task Atlas of Brain Recruitment During a Digital Game-based Program

Lumos Labs, Inc.1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2024年4月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
1
主要终点
Behavior response: Game score

研究概览

简要总结

Healthy volunteers ages 25-40 from the general US population who meet the eligibility criteria and are enrolled will (a) play Lumosity games at least 20 times each in under 60 days and (b) then complete one session of task-based functional magnetic resonance imaging (fMRI) while playing Lumosity games.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
25 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects 25-40 years of age.
  • Ability to understand and speak English, follow written and verbal instructions (English), and give informed consent (English), as assessed by the PI or project manager.
  • Ability to comply with all the testing and study requirements, including the ability to independently complete daily, online Lumosity games on a reliable, internet-connected device.
  • Geographical location within 100 miles of the study imaging center.

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 PI 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 PI may confound study data/assessments.
  • Any other medical condition in the last 90 days that in the opinion of the PI 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 online brain training programs (e.g., BrainHQ, Lumosity, Peak) for more than two weeks continuously.
  • 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.
  • Pregnancy, or strong likelihood of pregnancy.
  • Left-handed or ambidextrous.
  • Unwillingness or inability to comply with imaging safety protocols. Inability includes but is not limited to metal implants or exposure to shrapnel.
  • Any other condition that in the opinion of the PI may confound study data.

结局指标

主要结局

Behavior response: Game score

时间窗: Day 60

Score on game after completion of gameplay

Responder rates

时间窗: Day 60

Percentage of participants who show A) BOLD response by brain region during gameplay, B) Between-network connectivity, based on BOLD responses, during gameplay, C) Within-network connectivity, based on BOLD responses, during gameplay

Structural MRI volumetrics: Cortical thickness

时间窗: Day 60

Cortical thickness measured in millimeters

BOLD response during gameplay

时间窗: Day 60

Whole-brain blood oxygen level-dependent (BOLD) response during gameplay

Structural MRI volumetrics: Volume

时间窗: Day 60

Volume at rest

BAMS-7 (Brief Attention and Mood Scale of 7 Items)

时间窗: Day 60

Subject-reported BAMS-7 (Brief Attention and Mood Scale of 7 Items) including the Attention subscale, Mood subscale, and Total, measured post-imaging

Structural MRI volumetrics: Brain-Predicted Age Difference

时间窗: Day 60

Brain-Predicted Age Difference at rest

VGPQ (Video Game Playing Questionnaire)

时间窗: Day 60

Subject-reported VGPQ (Video Game Playing Questionnaire) including non-video game playing (NVGP) and video game playing (VGP)

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验