Prefrontal Cortex Dynamics of the Elderly During a Cognitive Stimulation Programme

NCT04693611 | Completed

• 1 other identifier: 16122020
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• 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

Other Outcomes (2)

• Sociodemographic information gathered through the sociodemographic questionnaire

  baseline

• Adherence to the intervention and dropouts evaluated through a session form

  during the intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL

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); Procedure: Functional near-infrared spectroscopy (fNIRS)

Control Group

NO INTERVENTION

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

Interventions

Individual cognitive stimulation therapy (iCST) BEHAVIORAL

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 Group

Functional near-infrared spectroscopy (fNIRS) PROCEDURE

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).

Intervention Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CEDIARA - Assoc. Solidariedade Social de Ribeira de Fráguas: lead

Study Sites (1)

Cediara - Social Solidarity Association of Ribeira de Fráguas

Ribeira de Fráguas, Albergaria-a-Velha, 3850-705, Portugal

Location

Related Publications (21)

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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. doi: 10.1076/1380-3395(200002)22:1;1-8;FT132.

  PMID: 10649552 BACKGROUND

• 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. doi: 10.1097/00002093-200101000-00001.

  PMID: 11236819 BACKGROUND

• Dubois B, Slachevsky A, Litvan I, Pillon B. The FAB: a Frontal Assessment Battery at bedside. Neurology. 2000 Dec 12;55(11):1621-6. doi: 10.1212/wnl.55.11.1621.

  PMID: 11113214 BACKGROUND

• 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

  BACKGROUND

• 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. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

  PMID: 1202204 BACKGROUND

• Freitas S, Simoes 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.

  PMID: 25531579 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 30906977 BACKGROUND

• Justo-Henriques SI, Otero P, Torres AJ, Vazquez FL. Effect of long-term individual cognitive stimulation intervention for people with mild neurocognitive disorder. Rev Neurol. 2021 Aug 15;73(4):121-129. doi: 10.33588/rn.7304.2021114. English, Spanish.

  PMID: 34308545 BACKGROUND

• 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.

  PMID: 18821046 BACKGROUND

• 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

  BACKGROUND

• 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. doi: 10.1176/appi.ajgp.12.4.395.

  PMID: 15249277 BACKGROUND

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

  BACKGROUND

• Pereira T, Castro MA, Villafaina S, Carvalho Santos A, Fuentes-Garcia 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):3917. doi: 10.3390/s20143917.

  PMID: 32674476 BACKGROUND

• Verhulsdonk S, Hellen F, Hoft 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.

  PMID: 25352352 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 22336813 BACKGROUND

• 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. doi: 10.1016/0022-3956(82)90033-4.

  PMID: 7183759 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Dementia; Neurocognitive Disorders; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Cognition Disorders

Study Officials

• Susana I Justo Henriques, 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

• João L Alves Apóstolo, Ph.D.

  Health Sciences Research Unit: Nursing (UICISA: E), Nursing School of Coimbra

  PRINCIPAL INVESTIGATOR

• Daniel F Borges Silva, M.Sc.

  Polytechnic Institute of Coimbra, Coimbra Health School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: January 5, 2021
• Study Start: April 14, 2021
• Primary Completion: April 30, 2021
• Study Completion: August 31, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)