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临床试验/NCT05929872
NCT05929872尚未招募不适用

The Efficacy of Strategic Memory Training Coupled With Non-invasive Brain Stimulation Techniques in Healthy Aging Population and Subjective Cognitive Decline Patients: a Randomized-controlled Study

IRCCS National Neurological Institute "C. Mondino" Foundation0 个研究点目标入组 56 人开始时间: 2023年7月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
56
主要终点
Associative learning test scores

研究概览

简要总结

Physiological aging is often associated with memory function decline. Recently, the use of transcranial direct current stimulation (tDCS), a type of non-invasive brain stimulation, has been combined with adaptive working memory training interventions in healthy older adults, providing evidence for a significant improvement in memory functions. To the best of our knowledge, no study addressed the use of strategic memory training coupled with the use of tDCS in normal aging. Strategic memory trainings allow to improve participants' performance in the practiced task and to generalize the use of memory strategies to new materials. This Randomized Controlled Trial (RCT) aims to evaluate the effectiveness of a combined intervention associating strategic memory training with the use of tDCS. Healthy older adults and participants with subjective cognitive decline will be recruited and randomly assigned to the experimental group (strategic memory training + ACTIVE tDCS) or the control group (strategic memory training + SHAM tDCS). All participants will be evaluated on transfer and practiced tasks before (T0) and after (T1) the treatment and during follow-up visits, scheduled at 1 month (T2) and 3 months (T3) after the intervention.

详细描述

The use of cognitive functions such as memory is essential for the execution of daily activities and represents a crucial element for autonomy maintenance during aging. It is known that the physiological cognitive decline associated with aging also involves memory and can significantly impact the older person's independence. For these reasons, great interest has been generated by two tools that have proved to be decisive in supporting memory functions: non-invasive neurostimulation and memory training. Transcranial direct current stimulation (tDCS) is a form of noninvasive brain stimulation that modulates brain activity by employing a direct current delivered through electrodes applied to the scalp. Recently, the use of tDCS has been combined with training interventions focused on working memory in healthy older adults, providing evidence of a significant improvement in memory function when memory training is associated with the use of tDCS compared to when it is performed without it. In particular, adaptive memory trainings coupled with stimulation of the dorsolateral prefrontal cortex provide benefits that last also at follow-up visits after 1 or 3 months, especially in participants who exhibit a lower baseline performance.

While it was observed that adaptive working memory training alone is unable to modulate brain plasticity mechanisms, it was hypothesized that tDCS can modulate brain plasticity by acting through long-term potentiation (LTP) mechanisms and that it can modulate brain neurotrophic factor (BDNF), a protein that plays a relevant role in LTP.

Several adaptive memory trainings focused on working memory, which is essential for decision-making processes and daily activities.

Even if promising results have been shown so far, it appears that no study addressed the implementation of strategic memory training coupled with the use of tDCS. Adaptive trainings allow improving the performance in each task by gradually increasing its difficulty, without however resorting to teaching a strategy. Strategic memory trainings permit not only to improve participants' performance in the practiced task but also to generalize the use of memory strategies to new tasks.

Intending to prevent cognitive impairment, using these intervention methods in healthy aging and the prodromal phases can be useful. To this end, subjective cognitive decline (SCD) indeed represents an intermediate state between normal cognition and mild cognitive impairment (nMCD) and may predict the development of objective cognitive decline.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

Double

入排标准

年龄范围
65 Years 至 85 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • GDS < e uguale
  • Age between 65 and 85 years.
  • Educational level ≥ 5 years.

排除标准

  • Pre-existing cognitive impairment (e.g. aphasia, neglect).
  • Dementia.
  • Severe disturbances in consciousness.
  • Concomitant severe psychiatric disease or other neurological conditions (e.g. depression and behavioral disorders).
  • Motor or sensory diseases that may interfere with test execution or strategic memory training.

结局指标

主要结局

Associative learning test scores

时间窗: 3 months (T3) after the end of the intervention program.

Participants are presented with 40 paired associates. Pairs consist of words chosen from Paivio, Yuille, and Madigan (1968) concreteness and imagery norms and from De Mauro, Mancini, Vedovelli, and Voghera (1993) word frequency norms. Each pair is printed in the middle of a 5 x 7 index card. The 40 cards are handed to participants, who are instructed to study the pairs for up to 20 minutes. After study, each stimulus is individually presented, and participants Are asked to write the corresponding response

次要结局

  • List learning tests scores(3 months (T3) after the end of the intervention program.)
  • Name-face learning test scores(3 months (T3) after the end of the intervention program.)
  • Place learning test scores(3 months (T3) after the end of the intervention program.)
  • Text learning test scores(3 months (T3) after the end of the intervention program.)
  • Grocery learning test scores(3 months (T3) after the end of the intervention program.)

研究者

申办方类型
Other
责任方
Sponsor

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