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临床试验/NCT01958437
NCT01958437已完成不适用

Enhancing Spatial Navigation Using Non-Invasive Brain Stimulation

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2013年10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
已完成
入组人数
44
试验地点
2
主要终点
Egocentric

研究概览

简要总结

Remembering how to travel from one location to another is critical in everyday life, yet this vital ability declines with normal aging and can be further affected by conditions that disproportionately affect the elderly, such as vision loss or progressive dementia. Human and animal research has shown that two distinct memory systems interact during navigation. The first, referred to as allocentric navigation, is very flexible and uses spatial knowledge of key features or landmarks to develop and use a mental map of the environment. This approach involves brain regions that are critical for new learning and memory but that decline with age. The second, referred to as egocentric navigation, is inflexible and relies on "habit" memories that link specific features with specific directions. This approach relies on brain regions that are critical for "automatic" responses and that are relatively unaffected by age.

The main problem is that allocentric navigation declines with age and is accompanied increased dependence on egocentric navigation. This change increases the risk of becoming disoriented or "lost" when traveling in unfamiliar areas or even when traveling new routes in familiar areas. Therefore, the main goal of this project is to examine whether non-invasive brain stimulation, specifically transcranial direct current stimulation, can improve allocentric navigation in healthy older adults and patients with mild cognitive impairment.

Participants will complete two functional magnetic resonance imaging sessions while learning new environments. Before one of these sessions, participants will receive active brain stimulation over the parietal cortex. Before the other session, participants will receive sham brain stimulation over the parietal cortex. The effects of this stimulation will be evaluated using both an allocentric and an egocentric memory test. Physiologic effects will be evaluated using both task-based and resting-state MRI.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

Double blinded

入排标准

年龄范围
50 Years 至 88 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •General inclusion criteria (all participants):
  • •All medications stable for approximately 1-2 months;
  • •No history of severe mental illness;
  • •No current untreated alcohol or substance abuse/dependence;
  • •English as native and preferred language;
  • •MRI-compatible if taking part in fMRI studies
  • •Able to give informed consent.
  • •MCI Inclusion Criteria:
  • •Diagnosis of amnestic MCI based on criteria set forth by Petersen (2004). Additionally, other potential causes of cognitive deficit ruled out by the referring physician;
  • •Healthy older adults
  • •intact cognitive functioning as measured by neuropsychological testing

排除标准

  • •History of neurological disease or injury
  • •History of severe mental illness
  • •Current untreated alcohol or substance abuse
  • •Other conditions may exclude; please discuss with contact

研究组 & 干预措施

Cognitively intact older adults - ACTIVE tDCS

Experimental

Group receives active brain stimulation

干预措施: Transcranial direct current stimulation (tDCS) (Device)

MCI ACTIVE tDCS

Active Comparator

Group receives active brain stimulation

干预措施: Transcranial direct current stimulation (tDCS) (Device)

Cognitively intact older adults - SHAM tDCS

Sham Comparator

Group receives sham brain stimulation

干预措施: Transcranial direct current stimulation (tDCS) (Device)

MCI SHAM tDCS

Sham Comparator

Group receives sham brain stimulation

干预措施: Transcranial direct current stimulation (tDCS) (Device)

结局指标

主要结局

Egocentric

时间窗: Outcome assessed after each of the 2 sessions

Number of turns correctly recalled for each egocentric environment

Accuracy in Centimeters From Target Location for Allocentric

时间窗: Outcome assessed after each of 2 sessions (estimated within 1 week of each other)

1 active tDCS; 1 sham tDCS for each measure. Participants touched a screen (using a ELO 19" touchscreen monitor) to document the location of the landmark. The distance between the actual vs. selected location served as the dependent measure.

Hippocampal BOLD Signal During Task-based fMRI

时间窗: change between active and sham tDCS sessions (<1month)

BOLD signal change comparing active to sham tDCS during Allocentric navigation (i.e., active HD-tDCS \> sham HD-tDCS). Activation maps thresholded at p\<.01 with minimum cluster size of 5 voxels.

Dorsal Attention Network Connectivity During Resting-state fMRI

时间窗: change between active and sham tDCS sessions (<1month)

Change in resting state functional connectivity strength between active and sham tDCS sessions. Strength is measured by Pearson r correlations between nodes, which are z-transformed, and summated.

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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