Non-invasive Transcranial Direct Current Stimulation to Improve Cognitive Efficiency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Complutense Verbal Learning Test (TAVEC) - Memory
研究概览
简要总结
Normal aging is associated with a progressive decline in cognitive functions, especially memory. This decline in cognitive function can negatively impact the quality of life of older adults. Although there are currently few possibilities to prevent and/or slow the signs of cognitive decline, both those associated with age and neurodegenerative pathologies, one of the non-invasive brain stimulation techniques that has gained attention in recent years is Transcranial Direct Current Stimulation (tDCS). tDCS is a technique based on the application of a low-intensity (< 2 mA) direct electrical current between two large-area electrodes placed on various surface areas of the head. Moreover, according to safety-related meta-analyses it is a very safe technique, without any major side effects, provided that internationally established safety protocols are taken into account in its application. This technique has recently been investigated as a potential treatment for both healthy elderly people and people with mild cognitive impairment and Alzheimer's disease in several cognitive variables, having shown encouraging results in working memory learning curves, modulation of plasticity and recognition tasks. This project aims to implement an intervention using transcranial direct current stimulation in healthy older adults, MCI and AD. The main objective is to test if there is an improvement in cognitive efficiency and if the changes are maintained over time (1 month). For this purpose, the effect of the technique will be studied on participants assigned to treatment and control groups, analyzing the possible modifications in the following cognitive variables: cognitive plasticity and learning potential, recognition and familiarity and false alarms.
详细描述
The clinical trial protocol involves the recruitment of participants from three different groups: healthy older adults, individuals with mild cognitive impairment (MCI), and patients with Alzheimer's disease (AD). Participants will be randomly assigned to either a treatment group or a control group.
For the treatment group, transcranial direct current stimulation (tDCS) will be administered over a specified period using a standard protocol involving the application of low-intensity electrical current (< 2 mA) through electrodes placed on specific scalp areas. The duration and frequency of stimulation will be predetermined based on scientific literature and established safety recommendations.
The control group will receive a sham procedure where a low-intensity current, having no effect on neuronal activity, will be applied to maintain treatment masking.
Prior to commencing the intervention, a baseline assessment of participants' cognitive functions will be conducted using a battery of standardized tests, including measures of cognitive plasticity, memory, attention, executive functions, and other relevant cognitive abilities.
During the intervention period, regular tDCS or placebo sessions will be conducted according to participants' assigned groups. Additionally, data on potential side effects and tolerability of the technique will be collected.
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
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For the group of healthy older adults:
- •MEC score greater than 26 points.
- •GDS between 1 and
- •For the MCI group:
- •MEC score between 21 and 26 points.
- •GDS between 1 and
- •For the mild EA group:
- •MEC score between 18 and 23 points.
- •GDS between 3 and 4.
排除标准
- •Presentation of contraindications to tDCS (presence of intracranial metal implants, intracranial hypertension, comitial risk).
- •Significant asymptomatic neurovascular disease
- •History of previous symptomatic stroke
- •Alcohol or drug abuse/dependence
- •Severe psychiatric symptoms
- •Depressive symptoms higher than mild
结局指标
主要结局
Complutense Verbal Learning Test (TAVEC) - Memory
时间窗: Baseline to approximately 4 weeks
This test presents a list of 16 words that, after being read by the evaluator, have to be repeated by the participant. The list is repeated five times (trials); the participant is again asked to remember the 16 words. The test was administered to evaluate the participant's immediate memory (Trial 1), learning ability (Trial 5 ). Post-intervention minus baseline. Scale is scored 0-16. Difference score range is (-16 to 16) with positive scores reflecting improvement.
Digits Wechsler Intelligence Scale for Adults-III (WAIS-III)
时间窗: Baseline to approximately 4 weeks
Direct and inverse digits of the Wechsler Intelligence Scale for Adults-III (Wechsler, 2001). These tests assess attentional capacity by exposing the participant to increasing amounts of information. On the direct digits task, which is used to assess immediate recall, the subject must repeat the sequence of numbers in the same order in which they are read by the examiner. On the inverse digit task, which assesses working memory and mental flexibility, the subject must say the digits backwards from the way they were presented by the examiner. Both tests are evaluated in the same way, assigning one point for each correct item, with a maximum score of 16 for both tests. Post-intervention minus baseline. Difference score range is (-16 to 16) with positive scores reflecting improvement.
Mini Mental State Examination
时间窗: Baseline to approximately 4 weeks
This is a screening test for general cognitive status. This test is evaluated on a maximum of 30 points. Participants with scores equal to or below 23 would be considered cognitively deficient. Post-intervention minus baseline. Scale is scored 0-30. Difference score range is (-30 to 30) with positive scores reflecting improvement.
次要结局
- Barcelona Test (BT) - Ability to Access and Recall Elements From the Lexical and Semantic Store(Baseline to approximately 4 weeks)
研究者
Juan Carlos Melendez
Coordinator of Doctoral Programme in Psychogerontology: Life Cycle Perspective
University of Valencia