Prefrontal Cortex Dynamics of the Elderly During a Cognitive Stimulation Programme: A Randomized and Controlled Trial in Old Adults With Normal Cognition and Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Cognitive functioning evaluated through Mini-Mental State Examination (MMSE)
研究概览
简要总结
This research aims to evaluate the effect of cognitive stimulation (CS) on the functioning of the prefrontal cortex (PFC), seeking an analysis of both cerebral hemodynamics in neuroplasticity and aspects related to the initiation of neurodegenerative processes. The intervention presents an individual format and the participants are elderly without or with neurocognitive disorders (NCD). Concretely, to assess the effects of individual CS on global cognition, and mood, as well as to analyze neuronal activity with oxygenation, volume and blood flow in the brain, evaluating the impact of cognitive stimulation on brain hemodynamics. Participants in the intervention group receive two 45 min-session of CS per week for 12 weeks in addition to their treatment as usual. Participants in the control group will maintain their treatment as usual.
详细描述
Faced with an unprecedented global ageing population and the current COVID-19 pandemic, the risk of social vulnerability increases in the elderly population, promoting the development and aggravation of neurodegenerative diseases, in particular NCD. The diagnostic criteria for this pathology emphasizes cognitive changes, and as such is based clinically on cognitive decline.
The PFC is considered the centre of cognitive function, where it encompasses attention, memory and executive functions.
Attention is the cognitive function that allows us to orient to the relevant stimuli and process them to respond accordingly. Given its functionality, it is distinguished into three types of attention: selective, divided and sustained. Attentional dysfunction can be present in several conditions where cognitive deficit is the main symptom, such as Alzheimer's disease.
With regard to memory, it is subdivided according to time storage, i.e. short or long term. Short-term memory is capable of operating with certain perceived information for a limited space of time and can later be forgotten or transferred to long-term memory. Two other complementary components are distinguished in this type of memory: immediate memory and recent memory. Long-term memory is a latent memory with unlimited capacity that can remain outside the conscious circuit until circumstances require another mode of response. It involves separate, interdependent and dynamic processes of storage, consolidation and evocation. It is made up of two major subsystems: implicit or non-declarative memory, and explicit or declarative memory.
Regarding executive functions, they designate the cognitive processes of control and integration aimed at the execution of behaviour directed at complex objectives, requiring sub-components such as attention, programming, time sequencing, inhibition of competing processes and information, monitoring and selection of strategies. Executive functions include various processes such as working memory, planning, response to reactions and error corrections, cognitive flexibility, inhibition, decision making.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being 65 years of age or older.
- •Being able to communicate and understand.
- •Being a native Portuguese speaker.
- •Educational level equal to or higher than 4 years old.
- •Have given informed consent for the project, duly completed and signed, after prior information.
- •Have a score of 22 or more points in the MMSE.
排除标准
- •Suffering from an acute or severe illness that prevent participation in the intervention sessions.
- •Severe sensory and physical limitations that prevent participation.
- •Low level of consciousness and minimal attention span.
- •Presence of severe neuropsychiatric symptoms (such as agitation, psychosis, severe depressive and anxiety symptoms, apathy), or presence of uncontrolled delirium that would prevent participation in the sessions.
- •History of seizures or cerebrovascular disease.
- •Movement disorders diagnosis.
- •Psychoactive substances consumption.
结局指标
主要结局
Cognitive functioning evaluated through Mini-Mental State Examination (MMSE)
时间窗: baseline
Significant statistic improvement in the participant's test scores between pre-intervention assessment and postintervention assessment. MMSE is a brief cognitive screening test. Scores range between 0-30 points. Higher scores indicate better cognitive function.
Change in cognitive functioning evaluated through MMSE
时间窗: 12 weeks after the beginning of the intervention
Significant statistic improvement in the participant's test scores between pre-intervention assessment and postintervention assessment. MMSE is a brief cognitive screening test. Scores range between 0-30 points. Higher scores indicate better cognitive function.
Executive functions evaluated through Frontal Assessment Battery (FAB)
时间窗: baseline
Significant statistic improvement in the participant's test scores between pre-intervention assessment and postintervention assessment. FAB assesses executive functions such as abstract thinking, mental flexibility, motor programming, interference sensibility, inhibitory control and environmental independence. Scores range between 0 - 18 points. Higher scores indicate better cognitive function.
Change in executive functions evaluated through FAB
时间窗: 12 weeks after the beginning of the intervention
Significant statistic improvement in the participant's test scores between pre-intervention assessment and postintervention assessment. FAB assesses executive functions such as abstract thinking, mental flexibility, motor programming, interference sensibility, inhibitory control and environmental independence. Scores range between 0 - 18 points. Higher scores indicate better cognitive function.
Prefrontal cortex activation pattern through a fNIRS
时间窗: baseline
Analysis of Oxyhemoglobin (HbO2) and Deoxyhemoglobin (HHb) variation in four regions of interest (ROIs) in the PFC: left prefrontal dorsolateral cortex (LDLPFC); left medial prefrontal cortex (LMPFC); right medial prefrontal cortex (RMPFC); right dorsolateral prefrontal cortex (RDLPFC). An increase in brain activity is generally assumed to reflect an increase in HbO2 and decrease in HHb as based on a mechanism known as neurovascular coupling.
Change in prefrontal cortex activation pattern through a fNIRS
时间窗: during the intervention
Analysis of Oxyhemoglobin (HbO2) and Deoxyhemoglobin (HHb) variation in four regions of interest (ROIs) in the PFC: left prefrontal dorsolateral cortex (LDLPFC); left medial prefrontal cortex (LMPFC); right medial prefrontal cortex (RMPFC); right dorsolateral prefrontal cortex (RDLPFC). An increase in brain activity is generally assumed to reflect an increase in HbO2 and decrease in HHb as based on a mechanism known as neurovascular coupling.
次要结局
- Depressive symptomatology assessed through the Geriatric Depression Scale-15 (GDS-15)(baseline)
- Change in depressive symptomatology assessed through the GDS-15(12 weeks after the beginning of the intervention)