CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 36 enrolled
Drug / intervention
Individual cognitive stimulation therapy (iCST) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04693611
NCT04693611N/ACompleted

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

CEDIARA - Assoc. Solidariedade Social de Ribeira de Fráguas·interventional·Posted Jan 5, 2021·Updated Sep 1, 2021

In Brief

A clinical study evaluating Individual cognitive stimulation therapy (iCST) and Functional near-infrared spectroscopy (fNIRS) for Dementia and 5 related conditions. Completed, enrolled 36 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPortugal
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJan 5, 2021
Enrollment StartApr 14, 2021
Primary CompletionApr 30, 2021
Study CompletionAug 31, 2021
TodayJul 2, 2026
Enrollment to primary: 16 daysPosted 5.5 years ago

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.

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).