Home-based Transcranial Alternating Current Stimulation (tACS) for Older Adults at Risk of Memory Decline
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Electroencephalography (EEG) measures
研究概览
简要总结
The proposed project aims to systematically examine the feasibility of remote, caregiver-led tACS for older adults who are vulnerable to memory decline.
详细描述
This is a feasibility study, which will include older adult participants (Ps) with memory deficits together with willing and able administrators (As) to administer tACS to the participants. This study will include 20 older Ps and 20 As to assess the feasibility of deploying home-based tACS in larger clinical trials, and to prepare for the development and implementation of such trials. The proposed project will systematically examine the feasibility of remote, caregiver-led tACS for older adults who are vulnerable to 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 of tACS as a part of memory decline prevention and treatment for older adults who have more difficulty reaching a clinic for treatment due to disability or who live more remotely.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants (Ps)
- •willing and capable to give informed consent for the participation in the study after it has been thoroughly explained
- •able and willing to comply with all study requirements
- •an informed consent form was signed
- •able to read, write, and communicate in English
- •able to identify an eligible administrator to participate with them in the study
- •Administrators (As)
- •at least 21 years of age
- •able to read, write, and communicate in English
- •self-reported computer proficiency and willingness to learn how to use tACS as defined by "yes" answers to the questions "Do you feel comfortable using a computer?" and "Are you willing to be the primary caregiver for a participant and learn how to administer tACS?"
- •stated availability during weekdays throughout the study period to administer tACS to the Ps
排除标准
- •Participants (Ps)
- •major psychiatric co-morbidity including major depressive disorder, schizophrenia or psychosis
- •blindness or other disabilities that prevent task performance
- •contraindications to tACS, as recorded on a standardized screening questionnaire, which include a reported seizure within the past two years, use of neuroactive drugs, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant, pacemaker, etc.)
- •the presence of any active dermatological condition, such as eczema, on the scalp a score of 18 or less on the Montreal Cognitive Assessment (MoCA) during the in-person screen
- •an inability to understand study procedures following review of the Informed Consent form
- •Understanding will be assessed by asking the participant to answer the following three questions: 1) What is the purpose of this study? 2) What are the risks of study involvement? 3) If you decide to participate, are you allowed to withdraw from the study at any time? Answers will be recorded by study personnel on the "Assessment of Protocol Understanding" form (see attached). Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator
- •Administrators (As)
- •mild cognitive impairment defined by a MoCA score ≤26 during the in-person screen
- •insufficient understanding of study procedures following review of the Informed Consent form
- •Understanding will be assessed by asking the participant to answer the following three questions: 1) What is the purpose of this study? 2) What are the risks of study involvement? 3) If you decide to participate, are you allowed to withdraw from the study at any time? Answers will be recorded by study personnel on the "Assessment of Protocol Understanding" form (see attached). Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator.
- •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
Electroencephalography (EEG) measures
时间窗: 48 weeks
High-density EEG (257 channels) will be recorded before and after the tACS intervention and changes in spatiotemporal dynamics in different frequency bands (theta, alpha, beta, gamma) will be assessed
Clinical Evaluation and Cognitive Assessment
时间窗: 48 weeks
a trained clinician will administer the Montreal Cognitive Assessment (MOCA) to characterize cognitive status and the level of dementia
次要结局
未报告次要终点
研究者
Alvaro Pascual-Leone
Senior Scientist
Hebrew SeniorLife