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临床试验/NCT06202872
NCT06202872已完成不适用

Memory Enhancement Using Transcranial Alternating Current Stimulation

Amsterdam UMC, location VUmc2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2024年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
26
试验地点
2
主要终点
Change in Rey Auditory Verbal Learning test scores

研究概览

简要总结

The 32 million Alzheimer's disease (AD) and 69 million prodromal AD patients worldwide contribute to a large economic burden. Effective and safe therapies that slow or prevent the progression from mild cognitive impairment (MCI) to AD are therefore of high priority. Transcranial alternating current stimulation (tACS) is a safe and patient-friendly non-invasive brain stimulation technique that serves as a potential candidate for reducing and/or slowing cognitive impairment. Application of tACS in the gamma frequency range, specifically around 40 Hz, has been studied in patients with AD and MCI due to AD. In these patients, a single session of 40 Hz tACS at the precuneus showed to improve episodic memory and to increase gamma power, as measured with electroencephalography. These findings will be replicated in the current study in patients with MCI due to AD, using magnetoencephalography (MEG) recorded before, during and after tACS. In this way, brain activity and network changes that underlie this improvement in episodic memory can be studied with greater temporal and spatial detail.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Recent (not more than 6 months ago) amnestic MCI diagnosis, which consensus is obtained in a multidisciplinary meeting after an extended multidisciplinary test battery at the memory clinic, including confirmation of AD pathology with cerebrospinal fluid biomarkers: abnormal p-tau/Aβ42 ratio of > 0.023

排除标准

  • Suffering from serious neurological, psychiatric or somatic comorbidity
  • Suffering from epileptic seizures or severe claustrophobia
  • Intensive use of psychoactive medication
  • Having a cardiac pacemaker, internal cardiac defibrillator or other intracorporeal device that interferes with MEG recordings

研究组 & 干预措施

Active tACS

Experimental

Gamma (40 Hz) tACS at the precuneus region

干预措施: Gamma (40 Hz) tACS at the precuneus region (Device)

Sham tACS

Sham Comparator

Sham tACS at the precuneus region

干预措施: Sham tACS at the precuneus region (Device)

结局指标

主要结局

Change in Rey Auditory Verbal Learning test scores

时间窗: Immediately before and after intervention

The Rey Auditory Verbal Learning (RAVL) test evaluates verbal episodic memory and is designed as a list-learning paradigm in which the subject hears a list of 15 nouns. The participant is asked to recall as many words from the list as possible after each of 5 repetitions of free-recall (total recall), and 15 minutes after an interference trial (long delayed recall). Scores range from 0 to 75 (total recall) and 0 to 15 (long delayed recall), with higher scores meaning a better outcome. An increase in RAVL test (total and long delayed recall) after active but not sham tACS is expected.

Change in Face-Name Association Task scores

时间窗: Immediately before and after intervention

The Face-Name Association Task assesses associative episodic memory and is a computer paradigm consisting of an encoding and a retrieval phase of face-name pairs. During the encoding phase, participants are instructed to remember a set of 12 faces and names they are paired. In two additional learning trials, participants are shown the previously learned faces and are asked to recall the correct name associated with each face (inital recognition). This recall of the correct name associated with a learned face is repeated 5 minutes after the learning trials during the retrieval phase (associative recognition). Scores range from 0 to 24 (inital recognition) and 0 to 12 (associative recognition), with higher scores meaning a better outcome. An increase in FNAT score (initial and associative recognition) after active but not sham tACS is expected.

次要结局

  • Change in spectral source space resting-state MEG (relative power)(Immediately before and after intervention)
  • Change in spectral source space resting-state MEG (posterior peak frequency)(Immediately before and after intervention)
  • Change in source space resting-state MEG network structure (MST variables)(Immediately before and after intervention)
  • Change in source space resting-state MEG network structure (modulatory index, degree and eigenvector centrality)(Immediately before and after intervention)
  • Change in functional connectivity source space resting-state MEG (AEC-c)(Immediately before and after intervention)
  • Change in functional connectivity source space resting-state MEG (PLI)(Immediately before and after intervention)
  • Change in source space resting-state MEG network structure (clustering coefficient and path length)(Immediately before and after intervention)

研究者

发起方
Amsterdam UMC, location VUmc
申办方类型
Other
责任方
Principal Investigator
主要研究者

Willem de Haan

Principal Investigator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

研究点 (2)

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