Study on the Effectiveness of the MTT24.5 Cognitive Training Program on Cognitive Skills, Brain Volume, and Activation (MTT245Cog)

August 11, 2024 updated by: Carol Kotliar, Institute for Biomedical Research, CONICET

Analysis of Efficacy of the Mental Training Tech 245: a Novel Method of Cognitive Stimulation Based on Brain Neuroplastic Ability

The goal of this study is to evaluate the effectiveness of a cognitive training program called Mental Training Tech 24.5 (MTT24.5). 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 MTT24.5 improves cognitive abilities and affects brain volume and activation.

The Main Questions it aims to answer are:

Does MTT24.5 improve overall cognitive performance and specific areas like memory, attention, and language skills? What effects does MTT24.5 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 MTT24.5 training versus a control group with no intervention. Participants will be randomly assigned to either the MTT24.5 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 24.5 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 MTT24.5 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 24.5' (MTT24.5) 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 MTT24.5 on cognitive abilities such as memory, attention, orientation, verbal fluency, language, and visuospatial skills.

Assess the effects of MTT24.5 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 MTT24.5 and its association with outcomes related to cognitive variables, as well as structural and/or 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, education/information, 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 www.who.int/chp/steps, and previously used in the Latin American OPTIMO study. This form will be administered to each subject at baseline (pre-intervention).
  • The Addenbrooke's 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:

MTT24.5 is a structured program consisting of 40 new pieces of knowledge and 100 learning techniques.developed as a binomial DATA/TECH 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 24.5 hours over 12 weeks, comprising weekly in-person training sessions of 1.5 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 individual's 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.

24.5 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 Type

Interventional

Enrollment (Actual)

75

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

  • Argentina
    • Buenos Aires
      • San Isidro, Buenos Aires, Argentina, 1643
        • Espacio Santa Maria

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults aged 21 years and above.
  • Ability to understand instructions for the training tasks.
  • Addenbrooke Cognitive Examination score >70.

Exclusion Criteria:

  • Planned absences that would hinder participation in the program.
  • Hearing, visual, or motor deficits that would impede participation in the program.
  • History of severe degenerative neurological diseases, as these conditions may significantly impact brain plasticity and cognitive abilities.
  • History of severe psychiatric disorders, as they may influence brain reorganization and complicate the interpretation of results.
  • Unstable treatment or planned changes in medication that may affect brain function and alter results.
  • History of current or recent excessive substance use (within the past 6 months), including alcohol or drugs, as these substances may influence brain function and neuroplasticity.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention group-MTT24.5
Subjects are assigned to 12 cognitive training in-person sessions of the MTT245 program by a validated trainer. Cognitive evaluations are made initially week 1 and at the end of the intervention at week 12.
Behavioral: Cognitive training
MTT24.5 consists in the learning of 40 new datas or knowledges, along 24.5 hours distributted on classes or sessions, during which an average of 3.5 new pieces of knowledge are taught and reinforced through training. Participants are trained using 4 techniques assigned to each new piece of information from a total of 100 available techniques. These techniques include the use of non-dominant skills, literacy in Braille for sighted individuals, and performing 5 actions simultaneously. Each technique is designed to aid in the memorization and learning of new knowledge
Other Names:
  • Mental Training Tech 245
No Intervention: Control group
Subjects are assigned to a controlled arm whereas no intervention were done. They should underwent the same cognitive evaluations than active comparator at week 1 and 12.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Global Cognitive Ability
Time Frame: immediately after the intervention
The primary study outcome, cognitive ability changes, was assessed through the difference between the post intervention Addenbrooke's Cognitive Examination III (ACE) score and the pre intervention ACE score. This score ranges from 0 to 100. he ACE Score ranges from 0 to 100. A value less than 85 es considered as cognitive moderate impairment.
immediately after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in memory, and /or attention, and/or verbal fluency, and/or language, and/or visuospatial skills abilities.
Time Frame: immediately after the intervention

Each ability outcome was assessed using the respective sub-dimensions of the ACE score and computing the difference between post intervention and pre intervention sub-score:

  • Memory ability sub-score
  • Attention ability sub-score
  • Orientation ability sub-score
  • Verbal fluency ability sub-score
  • Language ability sub-score
  • Visuospatial skills ability sub-score The memory ability sub-score ranges from 0 to 26, the attention abilities sub-score ranges from 0 to 8, the attention abilities sub-score ranges from 0 to 10, the verbal fluency sub-score ranges from 0 to 14, the language sub-score ranges from 0 to 16, and the visuospatial skills abilities sub-score ranges
immediately after the intervention
Rate of Adherence
Time Frame: immediately after the intervention
Adherence or compliance with the study protocol was assessed through the number of days that participant completed ("on site days"); as participants were instructed and reminded to complete weekly sessions, the number of active days was used as the primary measure of a participant's ongoing engagement and compliance with the study protocol.
immediately after the intervention
Change in Brain Volume and Activation
Time Frame: immediately after the intervention
Changes are reported as the volumes and/or activation obtained values of different structures of the brain, both in absolute terms (cm3) and relative (% of the total), and values reference of normal populations corrected for age and sex.
immediately after the intervention

Collaborators and Investigators

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

Sponsor

Institute for Biomedical Research, CONICET

Investigators

  • Principal Investigator: Carol V Kotliar, PhD, BIO
  • Principal Investigator: Carol V Kotliar, PhD, Institute for Biomedical Research, CONICET

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

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)

March 2, 2023

Primary Completion (Actual)

August 1, 2023

Study Completion (Actual)

October 30, 2023

Study Registration Dates

First Submitted

August 3, 2024

First Submitted That Met QC Criteria

August 7, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

August 14, 2024

Last Update Submitted That Met QC Criteria

August 11, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTT245Cog

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

At the time of publication, and upon aproval of the request by a scientific board, all IPD that underlie results in a publication will be shared.

IPD Sharing Time Frame

At the time of publication in a peer review journal

IPD Sharing Access Criteria

By written request to the PI, accompanied by a letter explaining objectives of the IPD to be shared and research group institution or antecedents of the individual if not an institution.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

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.

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