Ignite Creation Date:
2024-10-25 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549517
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-03
Brief Title:
Study on the Effectiveness of the MTT245 Cognitive Training Program on Cognitive Skills Brain Volume and Activation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Analysis of Efficacy of the Mental Training Tech 245 a Novel Method of Cognitive Stimulation Based on Brain Neuroplastic Ability
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MTT245Cog
Brief Summary:
The goal of this study is to evaluate the effectiveness of a cognitive training program called Mental Training Tech 245 MTT245 The program aims to enhance brain function and neuronal plasticity in adults who do not have any clinical cognitive impairment This study will help determine if MTT245 improves cognitive abilities and affects brain volume and activation
The Main Questions it aims to answer are
Does MTT245 improve overall cognitive performance and specific areas like memory attention and language skills What effects does MTT245 have on brain volume and activation How well do participants follow the program and what are their response patterns
Study Design
Researchers will compare the results of participation in the MTT245 training versus a control group with no intervention Participants will be randomly assigned to either the MTT245 program or the control group
The study involves adults aged 30 and older from the general population who do not have clinical cognitive impairment
The intervention includes attending 12 weekly in-person sessions each lasting about 2 hours for a total of 245 hours
The study will assess cognitive performance brain volume and activation as well as monitor adherence to the program and response patterns
Participants will
Engage in the MTT245 program or the control condition as assigned
Complete cognitive assessments to measure performance in various domains
Undergo brain imaging to evaluate changes in brain volume and activation
The Main Questions it aims to answer are
Does MTT245 improve overall cognitive performance and specific areas like memory attention and language skills What effects does MTT245 have on brain volume and activation How well do participants follow the program and what are their response patterns
Study Design
Researchers will compare the results of participation in the MTT245 training versus a control group with no intervention Participants will be randomly assigned to either the MTT245 program or the control group
The study involves adults aged 30 and older from the general population who do not have clinical cognitive impairment
The intervention includes attending 12 weekly in-person sessions each lasting about 2 hours for a total of 245 hours
The study will assess cognitive performance brain volume and activation as well as monitor adherence to the program and response patterns
Participants will
Engage in the MTT245 program or the control condition as assigned
Complete cognitive assessments to measure performance in various domains
Undergo brain imaging to evaluate changes in brain volume and activation
Detailed Description:
Neuronal plasticity presents a promising approach to addressing a pressing contemporary challenge the intersection of increased life expectancy with the risks of cognitive decline dementia and loss of independence A wealth of literature highlights the potential of various neuronal plasticity stimulation strategies in bolstering cognitive abilities However while much focus has been dedicated to using these techniques for neurological rehabilitation there remains a paucity of evidence regarding their efficacy in maintaining and enhancing cognitive functions in the generally healthy population In line with this the cognitive training protocol Mental Training Tech 245 MTT245 is grounded in the principles of neuronal plasticity and aims to improve cognitive development It specifically focuses on enhancing memory reasoning speed and attention in adults through a conceptual model that posits explicit learning as a direct stimulus for neuronal plasticity
II AIMS
Primary Objectives
Evaluate the effects of MTT245 on cognitive abilities such as memory attention orientation verbal fluency language and visuospatial skills
Assess the effects of MTT245 on brain structure and activation including brain volumes in globally standardized areas and those associated with cognitive abilities according to cognitive brain areas with taxonomic mapping
Determine if there are response phenotypes based on individual baseline characteristics such as age gender lifestyle factors medical history medications family history of dementia diet and baseline cognitive reserve score
Secondary Objective
Analyze the tolerance and adherence to MTT245 and its association with outcomes related to cognitive variables as well as structural andor functional brain changes
III METHODS
Design
This is a multisite prospective randomized open clinical study conducted between March and October 2023
Regulatory Approvals
The trial was approved by the review board and the local ethics committee All participants provided written consent This study followed the Consolidated Standards of Reporting Trials CONSORT reporting guideline
Evaluations
Cognitive Reserve Score CRS A validated cognitive reserve scale authorized from Roldan L et al The CRS records the frequency of cognitively stimulating activities carried out throughout life It includes 24 items distributed across four aspects activities of daily living educationinformation hobbies and social life The CRS will be obtained for each subject at baseline pre-intervention and after 12 weeks of participation
Medical and Lifestyle History Form A self-administered medical and lifestyle history form called STEPS 5 adapted from wwwwhointchpsteps and previously used in the Latin American OPTIMO study This form will be administered to each subject at baseline pre-intervention
The Addenbrookes Cognitive Examination-III ACE-III A brief cognitive test that evaluates five cognitive abilities attention memory verbal fluency language and visuospatial skills The ACE-III score will be obtained for each subject at baseline pre-intervention and post-intervention
Brain Magnetic Resonance Imaging BMRI Brain volume and activation information will be obtained from this study conducted on a subset of subjects at baseline pre-intervention and post-intervention
Description of the Intervention
MTT245 is a structured program consisting of 40 new pieces of knowledge and 100 learning techniquesdeveloped as a binomial DATATECH program provides the brain with new knowledge DATA classified into formal natural social and cultural areas The TECH consists of 100 high-impact cognitive stimulation modalities designed to enhance memory attention verbal fluency and visuospatial skills Techniques include methods such as learning to read the information in Braille writing it with the non-dominant hand or reinforcing the concept across various domains simultaneously Each piece of new information and technique is codified and identified with a number throughout the protocol This integration is intended to promotes changes in brain functionality improves synaptic efficiency and achieves permanent plastic changes The program spans approximately 245 hours over 12 weeks comprising weekly in-person training sessions of 15 hours each supplemented by an additional average of 4 hours of weekly online activities
The data or new knowledges were selected through an extensive search of relevant knowledge from the basic sciences natural cultural formal and social sciences To be included the data should be expressible in a concise concept stated in a maximum of 15 words around which an explanation is built using visual animation and emotional aspects or experiential learning during a 10-minute session The second part of the session aims to promote the integration of the new knowledge into an individuals cognitive reserve employing cognitive TECHS which consist of exercises designed for this purpose TECHS selection was based on a review of peer-reviewed articles demonstrating the effectiveness of cognitive training in improving specific cognitive abilities investigated in the study We identified 25 cognitive training studies with appropriate tools published between 2000 and 2022 The possible combinations of these tools yielded 75 possibilities regarding the association between 2 to 5 techniques for learning the same data indicating either consecutive or simultaneous actions
245 represents the total hours assigned to the program duration based on similar training distributions reported in the ACTIVE TRIAL The Advanced Cognitive Training for Independent and Vital Elderly
Detailed descriptions of the statistical analysis plan can be found in the attached document SA
II AIMS
Primary Objectives
Evaluate the effects of MTT245 on cognitive abilities such as memory attention orientation verbal fluency language and visuospatial skills
Assess the effects of MTT245 on brain structure and activation including brain volumes in globally standardized areas and those associated with cognitive abilities according to cognitive brain areas with taxonomic mapping
Determine if there are response phenotypes based on individual baseline characteristics such as age gender lifestyle factors medical history medications family history of dementia diet and baseline cognitive reserve score
Secondary Objective
Analyze the tolerance and adherence to MTT245 and its association with outcomes related to cognitive variables as well as structural andor functional brain changes
III METHODS
Design
This is a multisite prospective randomized open clinical study conducted between March and October 2023
Regulatory Approvals
The trial was approved by the review board and the local ethics committee All participants provided written consent This study followed the Consolidated Standards of Reporting Trials CONSORT reporting guideline
Evaluations
Cognitive Reserve Score CRS A validated cognitive reserve scale authorized from Roldan L et al The CRS records the frequency of cognitively stimulating activities carried out throughout life It includes 24 items distributed across four aspects activities of daily living educationinformation hobbies and social life The CRS will be obtained for each subject at baseline pre-intervention and after 12 weeks of participation
Medical and Lifestyle History Form A self-administered medical and lifestyle history form called STEPS 5 adapted from wwwwhointchpsteps and previously used in the Latin American OPTIMO study This form will be administered to each subject at baseline pre-intervention
The Addenbrookes Cognitive Examination-III ACE-III A brief cognitive test that evaluates five cognitive abilities attention memory verbal fluency language and visuospatial skills The ACE-III score will be obtained for each subject at baseline pre-intervention and post-intervention
Brain Magnetic Resonance Imaging BMRI Brain volume and activation information will be obtained from this study conducted on a subset of subjects at baseline pre-intervention and post-intervention
Description of the Intervention
MTT245 is a structured program consisting of 40 new pieces of knowledge and 100 learning techniquesdeveloped as a binomial DATATECH program provides the brain with new knowledge DATA classified into formal natural social and cultural areas The TECH consists of 100 high-impact cognitive stimulation modalities designed to enhance memory attention verbal fluency and visuospatial skills Techniques include methods such as learning to read the information in Braille writing it with the non-dominant hand or reinforcing the concept across various domains simultaneously Each piece of new information and technique is codified and identified with a number throughout the protocol This integration is intended to promotes changes in brain functionality improves synaptic efficiency and achieves permanent plastic changes The program spans approximately 245 hours over 12 weeks comprising weekly in-person training sessions of 15 hours each supplemented by an additional average of 4 hours of weekly online activities
The data or new knowledges were selected through an extensive search of relevant knowledge from the basic sciences natural cultural formal and social sciences To be included the data should be expressible in a concise concept stated in a maximum of 15 words around which an explanation is built using visual animation and emotional aspects or experiential learning during a 10-minute session The second part of the session aims to promote the integration of the new knowledge into an individuals cognitive reserve employing cognitive TECHS which consist of exercises designed for this purpose TECHS selection was based on a review of peer-reviewed articles demonstrating the effectiveness of cognitive training in improving specific cognitive abilities investigated in the study We identified 25 cognitive training studies with appropriate tools published between 2000 and 2022 The possible combinations of these tools yielded 75 possibilities regarding the association between 2 to 5 techniques for learning the same data indicating either consecutive or simultaneous actions
245 represents the total hours assigned to the program duration based on similar training distributions reported in the ACTIVE TRIAL The Advanced Cognitive Training for Independent and Vital Elderly
Detailed descriptions of the statistical analysis plan can be found in the attached document SA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None