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临床试验/NCT05293431
NCT05293431进行中(未招募)不适用

Characterization and Modulation of Brain Networks to Promote Brain Resilience for the Coronavirus (COVID-19) Pandemic

Institut Guttmann2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
40
试验地点
2
主要终点
Heart Rate

研究概览

简要总结

Background:

By the end of 2020, the coronavirus disease (COVID-19) pandemic resulted in over 84 million cases and nearly 2 million deaths.

Continued confinement and restriction are expected to negatively affect mental health, however, some individuals are likely to show much less negative impact than others. The characterization and neurobiological determinants of brain resilience vs vulnerability during the pandemic should generate critical knowledge and open future avenues for individually tailored interventions.

Objectives:

  1. Identify the individual psychobiological determinants of resilience during COVID-19 pandemic.
  2. Conduct a non-invasive brain stimulation intervention to modulate the expression of resilience brain networks.

Methods:

Barcelona Brain Health Initiative participants will be included, encompassing multiple assessments before and during the COVID-19 pandemic. Machine learning techniques will be applied to define brain networks signature of resilience. Subsequently transcranial alternating stimulation will be used during a controlled trial intervention to promote the expression of brain resilience networks.

Expected results:

The present project should provide critical new knowledge on brain mechanisms underlying resilience and first evidences of the feasibility and impact of modulating brain resilience networks in terms of its effects on mental health of participants.

详细描述

As of the end of 2020, the coronavirus (COVID-19) pandemic had resulted in over 88 million confirmed cases and nearly 2 million deaths worldwide. Recurring waves of infection are forcing to impose continuing social restrictions and confinement measures all around the world.

From a public health perspective, these measures could potentially have an important negative impact on society and has led to the call for development of preventive and interventional strategies.

However despite the generalized negative effects of infection some individuals seem relatively protected from negative sequelae. Therefore, some people appear to be particularly resilient and the characterization and better understanding of characteristics that explain why some remain resilient has been highlighted as a critical focus of needed research, as it allows the potential to identify factors that can be targets for designing interventional strategies.

Resilience, the concept that describes the capacity of certain individuals to resist the impact of illness and distress, is a broad term. In clinical psychology and mental health, the concept of resilience has been historically been linked to the study of individual differences (e.g., self-esteem, sense of control, perception of social support, etc.) that determine the capacity to cope with the impact of life traumas in order to maintain normal psychological and physical functioning and avoid serious mental illness.

Beyond the psychological aspects, the determinants and factors that confer individual differences in resilience require integrated assessment of specific person's social context, engagement in positive lifestyles, and their interplay with its brain biological substrates and mechanisms. Neuroimaging investigations have identified brain regions that show specific activity and connectivity patterns during exposure to stressful or violent stimuli and that may be correlated with scores in psychosocial scales of resilience or predict subsequent coping abilities. Within the field of ageing and dementia some studies have suggested the role of the frontal cortex, specifically the functional connectivity of the dorsolateral prefrontal cortex to the rest of the brain or to particular networks (DMN, SN), as a neural substrate of higher resilience, both in normal aging.

研究设计

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

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • No neurologic and neuropsychiatric diagnosis

排除标准

  • Contraindication to receive safety tACS

结局指标

主要结局

Heart Rate

时间窗: During the execution of the stress inducing paradigm administered immediately before and immediately after the non invasive brain stimulation (up to 15/20) minutes

During the stress inducing paradigm we will register heart rate variations

Stress scale

时间窗: The scale will be administered immediately before and immediately after the non invasive brain stimulation (up to 15/20) minutes

Holmes Stress Scale (HSS)

Resilience scale

时间窗: The scale will be administered immediately before and immediately after the non invasive brain stimulation (up to 15/20) minutes

Connor Davidson resilience scale (RISC-10)

Anxiety scale

时间窗: The scale will be administered immediately before and immediately after the non invasive brain stimulation (up to 15/20) minutes

State and Trait Anxiety Inventory the efficacy of the stimulations (STAI)

Skin conductance response

时间窗: During the execution of the stress inducing paradigm administered immediately before and immediately after the non invasive brain stimulation (up to 15/20) minutes

During the stress inducing paradigm we will register variations in the diameter of the pupil

Pupillary response

时间窗: During the execution of the stress inducing paradigm administered immediately before and immediately after the non invasive brain stimulation (up to 15/20) minutes

During the stress inducing paradigm we will register variations in the diameter of the pupil

EEG signal

时间窗: During the execution of the stress inducing paradigm administered immediately before and immediately after the non invasive brain stimulation (up to 15/20) minutes

We will explore changes in connectivity or oscillation of the network using EEG signal registered during the stress inducing task.

次要结局

未报告次要终点

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

PhD

Institut Guttmann

研究点 (2)

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