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临床试验/NCT06051071
NCT06051071招募中不适用

Home-based Transcranial Direct Current Stimulation to Modulate Neural Networks and Promote Resilience

Institut Guttmann2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
2
主要终点
Changes in the State-Trait Anxiety Inventory

研究概览

简要总结

Background:

Non-invasive brain stimulation showed to be effective in reduce stress related cognitive and mental-health consequences. Thanks to technological advances these devices are now very easy to use and suitable to hoe-based self-administration.

Objective:

Conduct a home-based and tele-supervised non-invasive brain stimulation intervention to modulate the expression of resilience brain networks.

Methods:

Transcranial direct current stimulation will be used duringa tele-supervised home-based stimulation intervention to promote the expression of brain resilience networks.

Expected results:

The present project should provide critical new knowledge and evidences of the feasibility and impact of modulating brain resilience networks in terms of its effects on mental health of participants, including the possibility to implement future self-administered, home-based interventions.

详细描述

Resilience, the concept that describes the ability of certain individuals to resist, among others, the impact of stress, is a broad term.

In clinical psychology and mental health, the concept of resilience has historically been linked to the study of individual differences (e.g. self-esteem, sense of control, perception of social support, etc.) that determine the ability to cope with the impact of life traumas and maintain good psychological and physical functioning, avoiding mental illness.

Neuroimaging research has identified brain regions that show patterns of specific activity and connectivity during exposure to stressful or violent stimuli and may be correlated with scores on psychosocial resilience scales or predict coping capabilities.

In the same vein, our group has recently observed how certain connectivity patterns between frontal and parietal areas related to the default neural network (DMN) and pedimental-parietal network (FPN), are predictive of better stress resilience, which decreases the negative impact on mental health.

Together, these findings suggest the possible existence of brain circuits composed of nodes within medial dorsolateral and prefrontal brain areas, and their connections to parietal areas, specifically related to resilience capacity.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • No psychiatric conditions or neurological disorders
  • Do not present any contraindication for their safety in relation to the TDCS protocol (crew metal implants, pacemakers, medical infusion bomb, epilepsy history, brain surgeries, etc.)

排除标准

  • alcohol or drug abuse
  • pregnancy

结局指标

主要结局

Changes in the State-Trait Anxiety Inventory

时间窗: immediately after the intervention

Anxiety scale scoring from 0 to 80 where higher scores indicates greater anxiety

Changes in the Holmes stress inventory

时间窗: immediately after the intervention

stress scale scoring from 0 to 430 points, where higher scores indicates greater stress

Adherence

时间窗: immediately after the intervention

number of sessions completed

Changes in the Connor Davidson resilience scale

时间窗: immediately after the intervention

A resilience scale scoring from 0 to 40, where higher score represent better resilience

次要结局

  • Skin electrical activity changes(immediately after the intervention)
  • Pupill dilatation changes(immediately after the intervention)
  • Heart rate variability changes(immediately after the intervention)
  • EEG signal changes(immediately after the intervention)

研究者

发起方
Institut Guttmann
申办方类型
Other
责任方
Principal Investigator
主要研究者

Javier Solana Sanchez

Principal Investigator

Institut Guttmann

研究点 (2)

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