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Prefrontal Cortex Dynamics of the Elderly During a Cognitive Stimulation Programme

Primary Purpose

Dementia, Neurocognitive Disorders, Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Individual cognitive stimulation therapy (iCST)
Functional near-infrared spectroscopy (fNIRS)
Sponsored by
CEDIARA - Assoc. Solidariedade Social de Ribeira de Fráguas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring brain activity, mood, functional near-infrared spectroscopy, prefrontal cortex, older adults, cognitive stimulation

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Cediara - Social Solidarity Association of Ribeira de Fráguas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

Participants who meet the inclusion criteria will be randomised to the CS intervention group or to the control group that will maintain their usual treatment. Participants in the intervention group will participate in two CS sessions per 12 weeks besides their treatment as usual.

Participants in the control group will maintain their usual treatment: social interaction activities, stimulation of personal skills, and any prescribed dementia-specific medication.

Outcomes

Primary Outcome Measures

Cognitive functioning evaluated through Mini-Mental State Examination (MMSE)
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
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)
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
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
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
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.

Secondary Outcome Measures

Depressive symptomatology assessed through the Geriatric Depression Scale-15 (GDS-15)
Participants' scores in the GDS-15. This instrument evaluated depressive symptoms using yes/no answers. Scores range between 0 and 15 points. Higher scores indicate more severe depressive symptoms.
Change in depressive symptomatology assessed through the GDS-15
Participants' scores in the GDS-15. This instrument evaluated depressive symptoms using yes/no answers. Scores range between 0 and 15 points. Higher scores indicate more severe depressive symptoms.

Full Information

First Posted
December 29, 2020
Last Updated
August 31, 2021
Sponsor
CEDIARA - Assoc. Solidariedade Social de Ribeira de Fráguas
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1. Study Identification

Unique Protocol Identification Number
NCT04693611
Brief Title
Prefrontal Cortex Dynamics of the Elderly During a Cognitive Stimulation Programme
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 14, 2021 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CEDIARA - Assoc. Solidariedade Social de Ribeira de Fráguas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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. There is evidence that in the early stages of NCD, people are able to learn and improve their cognitive function through interventions such as CS. CS is recommended by the National Institute for Health and Clinical Excellence as a non-pharmacological therapy for people with mild to moderate NCD and is an intervention where the cognitive domains are not used in isolation but integrated. An individual format is associated with better results. In a systematic review on CS, studies have shown strong evidence that CS has a positive impact on cognitive function, depression, daily life activities and behaviour for people with NCD. However, no studies are known that have analyzed prefrontal cortex activity in the elderly population associated with a functional method of infrared spectroscopy (fNIRS). This method provides information on hemodynamic changes associated with cortical activation by measuring in a non-invasive way changes in the relative ratios of deoxygenated hemoglobin (HHb) and oxygenated hemoglobin (HbO2). Monitoring and recording the dynamics in the PFC of the elderly during a cognitive stimulation programme with the fNIRS method may contribute to expanding knowledge about aspects related to neurodegenerative processes and cognitive function in the elderly.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Neurocognitive Disorders, Cognitive Impairment, Cognitive Dysfunction, Cognitive Decline, Cognition Disorders in Old Age
Keywords
brain activity, mood, functional near-infrared spectroscopy, prefrontal cortex, older adults, cognitive stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Participants who meet the inclusion criteria will be randomised to the CS intervention group or to the control group that will maintain their usual treatment. Participants in the intervention group will participate in two CS sessions per 12 weeks besides their treatment as usual.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants in the control group will maintain their usual treatment: social interaction activities, stimulation of personal skills, and any prescribed dementia-specific medication.
Intervention Type
Behavioral
Intervention Name(s)
Individual cognitive stimulation therapy (iCST)
Intervention Description
The intervention group will receive 24 individual CS sessions per participant. Each session will last approximately 45 minutes and will have the following structure: session introduction (5 minutes); reality orientation (10 minutes); stimulation of cognitive domain (25 minutes); session closure (5 minutes). The sessions will be led by a previously trained therapist. The intervention program will include several activities based on the principles of CS and adjusted for participants without any neurocognitive disorder.
Intervention Type
Procedure
Intervention Name(s)
Functional near-infrared spectroscopy (fNIRS)
Intervention Description
The acquisition by fNIRS will be performed in each CS session in four regions of interest (ROIs) in the prefrontal cortex: left dorsolateral prefrontal cortex (LDLPFC); left medial prefrontal cortex (LMPFC); right medial prefrontal cortex (RMPFC); right dorsolateral prefrontal cortex (RDLPFC).
Primary Outcome Measure Information:
Title
Cognitive functioning evaluated through Mini-Mental State Examination (MMSE)
Description
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.
Time Frame
baseline
Title
Change in cognitive functioning evaluated through MMSE
Description
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.
Time Frame
12 weeks after the beginning of the intervention
Title
Executive functions evaluated through Frontal Assessment Battery (FAB)
Description
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.
Time Frame
baseline
Title
Change in executive functions evaluated through FAB
Description
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.
Time Frame
12 weeks after the beginning of the intervention
Title
Prefrontal cortex activation pattern through a fNIRS
Description
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.
Time Frame
baseline
Title
Change in prefrontal cortex activation pattern through a fNIRS
Description
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.
Time Frame
during the intervention
Secondary Outcome Measure Information:
Title
Depressive symptomatology assessed through the Geriatric Depression Scale-15 (GDS-15)
Description
Participants' scores in the GDS-15. This instrument evaluated depressive symptoms using yes/no answers. Scores range between 0 and 15 points. Higher scores indicate more severe depressive symptoms.
Time Frame
baseline
Title
Change in depressive symptomatology assessed through the GDS-15
Description
Participants' scores in the GDS-15. This instrument evaluated depressive symptoms using yes/no answers. Scores range between 0 and 15 points. Higher scores indicate more severe depressive symptoms.
Time Frame
12 weeks after the beginning of the intervention
Other Pre-specified Outcome Measures:
Title
Sociodemographic information gathered through the sociodemographic questionnaire
Description
Participants' answers in the sociodemographic questionnaire designed specifically for this study. It gathers information about gender, age, marital status, formal education, which social response the participant attends, medical comorbidities and cognitive symptoms and will be administered to all participants.
Time Frame
baseline
Title
Adherence to the intervention and dropouts evaluated through a session form
Description
Adherence to the intervention and dropouts will be assessed using a session form, designed specifically for this study, completed by the technician after each session, regarding the attendance and mood/behavior of the participants throughout the intervention sessions.
Time Frame
during the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susana I Justo Henriques, Ph.D.
Organizational Affiliation
Health Sciences Research Unit: Nursing (UICISA: E), Nursing School of Coimbra
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rosa C Gomes Silva, Ph.D.
Organizational Affiliation
Health Sciences Research Unit: Nursing (UICISA: E), Nursing School of Coimbra
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Telmo A Santos Pereira, Ph.D.
Organizational Affiliation
Polytechnic Institute of Coimbra, Coimbra Health School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
João L Alves Apóstolo, Ph.D.
Organizational Affiliation
Health Sciences Research Unit: Nursing (UICISA: E), Nursing School of Coimbra
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel F Borges Silva, M.Sc.
Organizational Affiliation
Polytechnic Institute of Coimbra, Coimbra Health School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cediara - Social Solidarity Association of Ribeira de Fráguas
City
Ribeira De Fráguas
State/Province
Albergaria-a-Velha
ZIP/Postal Code
3850-705
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
No
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Links:
URL
https://www.ine.pt/xportal/xmain?xpid=INE&xpgid=ine_publicacoes&PUBLICACOESpub_boui=348174760&PUBLICACOESmodo=2
Description
2017 Demographic Statistics
URL
https://www.nice.org.uk/guidance/ng97/resources/dementia-assessment-management-and-support-for-people-living-with-dementia-and-their-carers-pdf-1837760199109
Description
Dementia: assessment, management and support for people living with dementia and their carers
URL
http://www.who.int/mediacentre/factsheets/fs381/en/
Description
Mental health and older adults

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Prefrontal Cortex Dynamics of the Elderly During a Cognitive Stimulation Programme

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