Prefrontal Cortex Dynamics of the Elderly During a Cognitive Stimulation Programme

Dementia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04693611
• Other study ID #: 16122020
• Status: Completed
• Phase: N/A
• Start date: April 14, 2021
• Est. completion date: August 31, 2021

Study information

• Verified date: February 2021
• Source: CEDIARA - Assoc. Solidariedade Social de Ribeira de Fráguas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 31, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognition Disorders
• Cognition Disorders in Old Age
• Cognitive Decline
• Cognitive Dysfunction
• Cognitive Impairment
• Dementia
• Disease
• Neurocognitive Disorders

Intervention

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).

Locations

Country	Name	City	State
Portugal	Cediara - Social Solidarity Association of Ribeira de Fráguas	Ribeira De Fráguas	Albergaria-a-Velha

Sponsors (1)

Lead Sponsor	Collaborator
CEDIARA - Assoc. Solidariedade Social de Ribeira de Fráguas

Country where clinical trial is conducted

Portugal, 

References & Publications (21)

Apóstolo J, Loureiro L, Reis I, Silva I, Cardoso D, Sfetcu R. Contribution to the adaptation of the Geriatric Depression Scale -15 into Portuguese. Revista de Enfermagem Referência. 2014; IV(3): 65-73. doi: 10.12707/RIV14033

Apóstolo JLA, Bobrowicz-Campos EM, dos Reis IAC, Henriques SJ, Correia CAV. Exploring the screening capacity of the European Portuguese version of the 15-item Geriatric Depression Scale. Revista de Psicopatología y Psicología Clínica. 2018; 23: 99-107. doi: 10.5944/rppc.vol.23.num.2.2018.21050

Clare L, Wilson BA, Carter G, Breen K, Gosses A, Hodges JR. Intervening with everyday memory problems in dementia of Alzheimer type: an errorless learning approach. J Clin Exp Neuropsychol. 2000 Feb;22(1):132-46. — View Citation

Clare L, Woods RT. Cognitive training and cognitive rehabilitation for people with early-stage Alzheimer's disease: A review. Neuropsychological Rehabilitation. 2004; 14: 385-401. doi: 10.1080/09602010443000074

Davis RN, Massman PJ, Doody RS. Cognitive intervention in Alzheimer disease: a randomized placebo-controlled study. Alzheimer Dis Assoc Disord. 2001 Jan-Mar;15(1):1-9. — View Citation

Dubois B, Slachevsky A, Litvan I, Pillon B. The FAB: a Frontal Assessment Battery at bedside. Neurology. 2000 Dec 12;55(11):1621-6. — View Citation

Filipin F, Feldman M, Taragano FE, Martelli M, Sánchez V, García V, et al. The efficacy of cognitive stimulation on depression and cognition in elderly patients with cognitive impairment: A retrospective cohort study. AIMS Medical Science. 2015; 3(1): 1-14. doi: 10.3934/medsci.2016.1.1

Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. — View Citation

Freitas S, Simões MR, Alves L, Santana I. The Relevance of Sociodemographic and Health Variables on MMSE Normative Data. Appl Neuropsychol Adult. 2015;22(4):311-9. doi: 10.1080/23279095.2014.926455. Epub 2014 Dec 22. — View Citation

Guerreiro M, Silva AP, Botelho MA, Leitão O, Castro-Caldas A, Garcia C. Adaptação à população portuguesa da tradução do Mini Mental State Examination. Revista Portuguesa de Neurologia. 1994; 1: 9-10.

Justo-Henriques SI, Marques-Castro AE, Otero P, Vazquez FL, Torres AJ. [Long-term individual cognitive stimulation program in patients with mild neurocognitive disorder: a pilot study]. Rev Neurol. 2019 Apr 1;68(7):281-289. doi: 10.33588/rn.6807.2018321. Spanish. — View Citation

Justo-Henriques SI, Otero P, Torres A, Vázquez F. Effect of long-term individual cognitive stimulation program for people with mild neurocognitive disorder. Psychiatry Research. In press.

Lima CF, Meireles LP, Fonseca R, Castro SL, Garrett C. The Frontal Assessment Battery (FAB) in Parkinson's disease and correlations with formal measures of executive functioning. J Neurol. 2008 Nov;255(11):1756-61. doi: 10.1007/s00415-008-0024-6. Epub 2008 Sep 25. — View Citation

Lobbia A, Carbone E, Faggian S, Gardini S, Piras F, Spector E, et al. The efficacy of cognitive stimulation therapy (CST) for people with mild-to-moderate dementia: A review. European Psychologist. 2018; 24(3): 257-277. doi: 10.1027/1016-9040/a000342

Loewenstein DA, Acevedo A, Czaja SJ, Duara R. Cognitive rehabilitation of mildly impaired Alzheimer disease patients on cholinesterase inhibitors. Am J Geriatr Psychiatry. 2004 Jul-Aug;12(4):395-402. — View Citation

Morgado J, Rocha CS, Maruta C, Guerreiro M, Martins IP. Novos valores normativos do Mini-Mental State Examination. Sinapse. 2009; 2: 10-16.

Pereira T, Castro MA, Villafaina S, Carvalho Santos A, Fuentes-García JP. Dynamics of the Prefrontal Cortex during Chess-Based Problem-Solving Tasks in Competition-Experienced Chess Players: An fNIR Study. Sensors (Basel). 2020 Jul 14;20(14). pii: E3917. doi: 10.3390/s20143917. — View Citation

Verhülsdonk S, Hellen F, Höft B, Supprian T, Lange-Asschenfeldt C. Attention and CERAD test performances in cognitively impaired elderly subjects. Acta Neurol Scand. 2015 Jun;131(6):364-71. doi: 10.1111/ane.12346. Epub 2014 Oct 28. — View Citation

Wilson B. Towards a comprehensive model of cognitive rehabilitation. Neuropsychological Rehabilitation. 2002; 12(2): 97-110. doi: 10.1080/09602010244000020

Woods B, Aguirre E, Spector AE, Orrell M. Cognitive stimulation to improve cognitive functioning in people with dementia. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD005562. doi: 10.1002/14651858.CD005562.pub2. Review. — View Citation

Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, Adey M, Leirer VO. Development and validation of a geriatric depression screening scale: a preliminary report. J Psychiatr Res. 1982-1983;17(1):37-49. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sociodemographic information gathered through the sociodemographic questionnaire	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
Other	Adherence to the intervention and dropouts evaluated through a session form	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
Primary	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.	baseline
Primary	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.	12 weeks after the beginning of the intervention
Primary	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.	baseline
Primary	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.	12 weeks after the beginning of the intervention
Primary	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.	baseline
Primary	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.	during the intervention
Secondary	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.	baseline
Secondary	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.	12 weeks after the beginning of the intervention

External Links

•   2017 Demographic Statistics
•   Aging and life cycle
•   Dementia: assessment, management and support for people living with dementia and their carers
•   Mental health and older adults