Prefrontal Cortex Dynamics of the Elderly During a Cognitive Stimulation Programme

August 31, 2021 updated by: CEDIARA - Assoc. Solidariedade Social de Ribeira de Fráguas

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
    • Albergaria-a-Velha
      • Ribeira De Fráguas, Albergaria-a-Velha, Portugal, 3850-705
        • Cediara - Social Solidarity Association of Ribeira de Fráguas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group

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.
Behavioral: Individual cognitive stimulation therapy (iCST)
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.
Procedure: Functional near-infrared spectroscopy (fNIRS)
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).
No Intervention: Control Group
Participants in the control group will maintain their usual treatment: social interaction activities, stimulation of personal skills, and any prescribed dementia-specific medication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive functioning evaluated through Mini-Mental State Examination (MMSE)
Time Frame: 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.
baseline
Change in cognitive functioning evaluated through MMSE
Time Frame: 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.
12 weeks after the beginning of the intervention
Executive functions evaluated through Frontal Assessment Battery (FAB)
Time Frame: 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.
baseline
Change in executive functions evaluated through FAB
Time Frame: 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.
12 weeks after the beginning of the intervention
Prefrontal cortex activation pattern through a fNIRS
Time Frame: 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.
baseline
Change in prefrontal cortex activation pattern through a fNIRS
Time Frame: 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.
during the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive symptomatology assessed through the Geriatric Depression Scale-15 (GDS-15)
Time Frame: baseline
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.
baseline
Change in depressive symptomatology assessed through the GDS-15
Time Frame: 12 weeks after the beginning of the intervention
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.
12 weeks after the beginning of the intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sociodemographic information gathered through the sociodemographic questionnaire
Time Frame: baseline
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.
baseline
Adherence to the intervention and dropouts evaluated through a session form
Time Frame: during the intervention
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.
during the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CEDIARA - Assoc. Solidariedade Social de Ribeira de Fráguas

Investigators

  • Principal Investigator: Susana I Justo Henriques, Ph.D., Health Sciences Research Unit: Nursing (UICISA: E), Nursing School of Coimbra
  • Principal Investigator: João L Alves Apóstolo, Ph.D., Health Sciences Research Unit: Nursing (UICISA: E), Nursing School of Coimbra
  • Principal Investigator: Rosa C Gomes Silva, Ph.D., Health Sciences Research Unit: Nursing (UICISA: E), Nursing School of Coimbra
  • Principal Investigator: Telmo A Santos Pereira, Ph.D., Polytechnic Institute of Coimbra, Coimbra Health School
  • Principal Investigator: Daniel F Borges Silva, M.Sc., Polytechnic Institute of Coimbra, Coimbra Health School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2021

Primary Completion (Actual)

April 30, 2021

Study Completion (Actual)

August 31, 2021

Study Registration Dates

First Submitted

December 29, 2020

First Submitted That Met QC Criteria

December 31, 2020

First Posted (Actual)

January 5, 2021

Study Record Updates

Last Update Posted (Actual)

September 1, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16122020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neurocognitive Disorders

Clinical Trials on Individual cognitive stimulation therapy (iCST)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe