跳至主要内容
临床试验/NCT06549517
NCT06549517已完成不适用

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

Institute for Biomedical Research, CONICET2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2023年3月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
2
主要终点
Change in Global Cognitive Ability

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Change in Global Cognitive Ability

时间窗: 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.

次要结局

  • Change in memory, and /or attention, and/or verbal fluency, and/or language, and/or visuospatial skills abilities.(immediately after the intervention)
  • Rate of Adherence(immediately after the intervention)
  • Change in Brain Volume and Activation(immediately after the intervention)

研究者

发起方
Institute for Biomedical Research, CONICET
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carol Kotliar

Chief Clinical Research Laboratory

Institute for Biomedical Research, CONICET

研究点 (2)

Loading locations...

相似试验

Study on the Effectiveness of the MTT24.5 Cognitive... | 临床试验