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临床试验/NCT05457725
NCT05457725招募中不适用

Characterizing and Modulating Neurocognitive Processes of Learning to Trust and Distrust in Aging II

University of Florida1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年10月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
68
试验地点
1
主要终点
Behavioral Benefits

研究概览

简要总结

Much of human interaction is based on trust. Aging has been associated with deficits in trust-related decision making, likely further exacerbated in age-associated neurodegenerative disease (Alzheimer's disease/AD), possibly underlying the dramatically growing public health problem of elder fraud. Optimal trust-related decision making and avoiding exploitation require the ability to learn about the trustworthiness of social partners across multiple interactions, but the role that learning plays in determining age deficits in trust decisions is currently unknown.

Aim: Probe the malleability of the underlying neurocircuitry of trust-learning deficits in aging. This study will utilize real-time fMRI neurofeedback to train older adults in brain activity up-regulation toward enhanced trust-related learning in aging and confirm critical mechanisms of experience-dependent social decisions in aging.

Grant R01AG072658 Aim 3: Test the malleability of trust-learning neurocircuitry toward optimized trust-related decision making in aging.

详细描述

This study will apply rtfMRI neurofeedback training as an intervention method, to demonstrate that older adults can be trained in volitional brain activity up-regulation, reducing their trust-learning deficits. The study will comprises several MRI sessions including pre-training, training, and post-training scans.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participant and outcome assessor are not aware of the experimental vs. control

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Able to provide verbal and written informed consent
  • •Fluent English speaker
  • •At least 8th grade education
  • •On stable medication regimen

排除标准

  • •Pregnancy
  • •Magnetic resonance imaging contraindications (e.g., certain metallic objects in body, claustrophobia)
  • •Current major depression defined as scores >14 on the Beck Depression Inventory-II
  • •Impaired scores on the Telephone Interview for Cognitive Status (TICS; cut-off of >30)
  • •Current use of medications with significant anticholinergic properties due to potential influence on memory ("memory enhancing"; e.g., Aricept or Namenda)
  • •Current use of anticonvulsant, neuroleptic, sedatives, or other medications known to affect cognition
  • •Uncorrected visual and hearing impairments
  • •Neurologic conditions affecting the brain (e.g., severe stroke, epilepsy, traumatic brain injury with >30-minute loss of consciousness)
  • •Impaired scores on a cognitive screening measure, the Montreal Cognitive Assessment (MoCA); for older adults the cutoff will be age and education corrected
  • •Unstable medical illness (e.g., metastatic cancer)
  • •Significant cardiovascular conditions (e.g., major heart attack)
  • •Will not exclude participants who are taking anti-depressant medications. Use of antidepressants (particularly SSRI's) and anxiolytic medications will be recorded and included in post-hoc analyses

研究组 & 干预措施

Contingent rtfMRI neurofeedback training

Experimental

Contingent rtfMRI neurofeedback training will follow an alternating up-regulation/rest block design with screen-color cues. Visual feedback about real-time brain activity in the ROI will be provided (e.g., via a thermometer bar). During resting blocks, the thermometer bar remains static.

干预措施: Contingent rtfMRI neurofeedback training (Behavioral)

Non-contingent/sham rtfMRI neurofeedback training

Sham Comparator

Non-contingent/sham rtfMRI neurofeedback training will follow an alternating up-regulation/rest block design with screen-color cues. Visual feedback about non-contingent/sham brain activity in the ROI will be provided (e.g., via a thermometer bar). During resting blocks, the thermometer bar remains static.

干预措施: Non-contingent/sham rtfMRI neurofeedback training (Behavioral)

结局指标

主要结局

Behavioral Benefits

时间窗: at baseline and after training completion about 1 week later

Increase in trust-related learning reflected in greater accuracy (e.g., in percent) on trust learning task

Neurofeedback Training Success

时间窗: at baseline and after training completion about 1 week later

Increase in BOLD signal in ROI during up-regulation trials administration of computerized learning tasks, with contrasting groups and conditions

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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