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临床试验/NCT07441122
NCT07441122招募中不适用

Building Cognitive Reserve Through Brain-Computer-Interfaces

University of Texas at Austin2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年7月1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
100
试验地点
2
主要终点
Change in neural correlates of attention across different intervention sessions

研究概览

简要总结

Cognitive reserve refers to the brain's ability to maintain cognitive performance despite age-related changes or neuropathology. Enhancing cognitive reserve is thought to delay cognitive decline and improve functional outcomes in aging and neurodegenerative conditions. Attention and memory-related neural processes are considered key contributors to cognitive reserve, yet it remains unclear whether these neural markers can be deliberately strengthened through targeted training and non-invasive interventions.

The goal of this clinical study is to investigate whether mindfulness-based meditation and non-invasive brain stimulation can enhance neural markers of attention and memory that serve as proxies for cognitive reserve in cognitively healthy adults and older adults diagnosed with mild cognitive impairment (MCI). Investigators hypothesize that strengthening these neural markers will lead to measurable improvements in cognitive reserve-related functions in both healthy aging and MCI populations.

This study further hypothesizes that neural markers of attention can be selectively enhanced using an electroencephalography (EEG)-based brain-computer interface (BCI) combined with non-invasive interventions such as mindfulness-based relaxation or neuromodulation. During the study, participants will perform a computerized memory task while their EEG signals are recorded in real time. A BCI will analyze these signals to decode the presence or absence of the P300 event-related potential, a well-established neural marker of attentional control and cognitive resource allocation. Real-time feedback and intervention will be used to modulate these neural processes with the goal of promoting adaptive changes in attention-related brain activity.

By integrating EEG-based decoding, behavioral training, and non-invasive interventions, this study aims to determine whether targeted modulation of attention-related neural activity can support cognitive reserve in aging and mild cognitive impairment.

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
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Younger adults:
  • •Good general health.
  • •Normal or corrected vision.
  • •no history of neurological/psychiatric disease
  • •ability to read and understand English
  • •ability to understand information and ability to give a free and informed consent
  • •Older adults:
  • •Normal or corrected vision.
  • •Self-reports no current diagnosis of dementia.
  • •Ability to provide written/electronic, informed consent.

排除标准

  • •Younger Adults:
  • •Neurological or psychiatric diseases that could be contraindicated for tACS (e.g., personal history of epilepsy/seizure brain damage, history of fainting, bipolar disorder, schizophrenia, current substance use disorder, etc.).
  • •Medications that elevate seizure threshold (e.g., stimulant medication, high dose bupropion).
  • •Factors hindering EEG acquisition and tACS delivery (e.g., skin infection, wounds, dermatitis, inability to access the scalp of the participant).
  • •Older Adults:
  • •Neurological or psychiatric diseases that could be contraindicated for tACS (e.g., personal history of epilepsy/seizure brain damage, pacemakers, history of fainting, bipolar disorder, schizophrenia, current substance use disorder, etc.).
  • •Medications that elevate seizure threshold (e.g., stimulant medication, high dose bupropion).
  • •Factors hindering EEG acquisition and tACS delivery (e.g., skin infection, wounds, dermatitis, inability to access the scalp of the participant).
  • •Diagnosis of dementia.
  • •Do not have the capacity to provide informed consent.

研究组 & 干预措施

Behavior-based Attention control with Open-Loop tACS

Active Comparator

Subjects complete an nback task after a tACS intervention in which ground truth visual feedback is provided at the end of each run.

干预措施: transcranial electrical stimulation (Device)

EEG-Based Attention Control and Open-Loop tACS

Experimental

Subjects complete an nback task in which EEG-based visual feedback is provided after each trial

干预措施: transcranial electrical stimulation (Device)

EEG-based Attention Control and Meditation

Experimental

Subjects complete an nback task in which EEG-based visual feedback is provided after each trial

干预措施: Mindfulness Meditation (Behavioral)

Behavior-based Attention control with Meditation

Active Comparator

Subjects complete an nback task after a meditation intervention in which ground truth visual feedback is provided at the end of each run.

干预措施: Mindfulness Meditation (Behavioral)

结局指标

主要结局

Change in neural correlates of attention across different intervention sessions

时间窗: From enrollment to the end of the study after 3 days (young adults) or 8 days (older adults)

This outcome measures whether neural correlates of attentional markers (e.g. amplitude, peak-to-peak, band power and connectivity measures of neural correlates) change across sessions as a result of intervention.

次要结局

  • Change in correct answer rate of memory task across intervention sessions(From enrollment to the end of the study after 3 days (young adults) or 8 days (older adults))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jose del R. Millan

Principal Investigator

University of Texas at Austin

研究点 (2)

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