NCT05708001招募中不适用
Improvement of Memory in Mild Cognitive Impairment (MCI) Using Transcranial Alternating Current Stimulation (tACS) Guided by EEG and MRI: a Randomized, Sham-controlled, Parallel-arm, Double-blind Study
Lucie Bréchet2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- cognitive status measured by Montreal Cognitive Assessment (MoCA)
研究概览
简要总结
The Clinical Trial will systematically examine the feasibility of remote, caregiver-led tACS for older adults with memory deficits and evaluate whether repeated tACS leads to sustained improvement of neuronal activity and memory functions.
详细描述
The proposed investigation will systematically examine the feasibility and efficacy of remote, caregiver-led tACS for older adults with memory decline. This study will provide data to support the safety and effectiveness of home-based tACS in this population and will lead to future research to increase access to tACS as a part of memory decline prevention and treatment for older adults.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mild Cognitive Impairment (MCI) patients
- •age ≥ 55 years old
- •clinical diagnosis of mild cognitive impairment (MCI) based on a comprehensive clinical assessment and standard neuropsychological examination including tests of language, visuospatial thinking, executive functions, and memory
- •confirmation of diagnosis will be made by Prof. Paul Unschuld, the study MD, based on a participant's cognitive evaluation and history
- •understanding of the informed consent
- •able and willing to comply with all study requirements
- •informed consent form was signed
- •women of childbearing potential (WOCBP) must perform a pregnancy test during screening
- •minimum 21 years of age
- •self-reported computer/tablet proficiency
- •willingness to learn how to use tACS
- •availability during the study period to administer tACS to the participant
- •informed consent form was signed
- •women of childbearing potential (WOCBP) must perform a pregnancy test during screening
排除标准
- •Mild Cognitive Impairment (MCI) patients
- •age < 55 years old
- •any current diagnosis of a psychiatric disorder (e.g., schizophrenia, bipolar disorder, depressive disorder)
- •other than MCI, any history of other progressive or genetic neurologic disorder (e.g., Parkinson's disease, multiple sclerosis, tubular sclerosis) or acquired neurological disease (e.g., stroke, traumatic brain injury, tumor), including intracranial lesions
- •history of head trauma resulting in prolonged loss of consciousness
- •current history of poorly controlled headaches including chronic medication for migraine prevention
- •history of fainting spells of unknown or undetermined etiology that might constitute seizures
- •history of seizures, diagnosis of epilepsy
- •any unstable medical condition or chronic uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
- •contraindication for undergoing MRI or receiving tACS
- •any metal in the brain or skull (excluding dental fillings) or elsewhere in the body unless cleared by the responsible covering MD (e.g., MRI compatible joint replacement)
- •any skin problems, such as dermatitis, psoriasis, or eczema
- •any electrically, magnetically, or mechanically activated implanted devices such as a pacemaker, intracranial electrodes, implanted defibrillators, medication pumps, nerve stimulators, vascular clips, or any other prosthesis in the brain
- •any serious life-threatening disease such as congestive heart failure, pulmonary obstructive chronic disease, or active neoplasia
- •pregnant women
- •adults lacking capacity for consent
- •insufficient understanding of study procedures
- •poor eyesight, severe arthritis in the hands, pain, deformity or other condition that interferes with successful administration of tACS
结局指标
主要结局
cognitive status measured by Montreal Cognitive Assessment (MoCA)
时间窗: baseline, after 4 weeks
The primary objective is to characterize cognitive status at baseline and after 4 weeks of the home-based stimulation intervention.
次要结局
- modulation of gamma activity assessed with high-density EEG(baseline, after 4 weeks,)
研究者
Lucie Bréchet
Sponsor-Investigator
University of Geneva, Switzerland
研究点 (2)
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