NCT05077826已完成不适用
Modern Energetic Methods of Response Improvement (MEMORI)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Learning Task Performance
研究概览
简要总结
The investigators have developed a low-risk transcranial Electrical Stimulation (tES) treatment that has improved learning and performance in young adults up to nearly 4 times when compared with a sham control. This randomized pilot trial will determine if this same tES protocol improves memory in older adults (50-90 years old) who are healthy, and separately in older adults with mild cognitive impairment (MCI) or early stage Alzheimer's disease (AD). TES will be applied to the right temple and left arm for up to 40 minutes. MRI images, along with other measures, may be obtained before and after tES. If effective, this intervention may help to improve the quality of life for AD patients and their families.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for healthy participants:
- •50-90 years of age, as verified via photo identification with date of birth.
- •Should be right-handed and learned English by seven years old.
- •Generally healthy
- •Inclusion criteria for participants with MCI or AD:
- •50-90 years of age, as verified via photo identification with date of birth.
- •Should be right-handed and learned English by seven years old.
- •Is legally able to sign the consent form on their own behalf, or has a legally authorized representative that is able to sign.
- •Has a caregiver that can assist with taking health history.
排除标准
- •Exclusion criteria for healthy participants:
- •Significant history of psychiatric disorders or current psychosis including self-report or Geriatric Depression Scale short form score-GDS >5 if uncertain.
- •Current excessive drug, alcohol or nicotine use defined by participant self-report.
- •History of epilepsy, migraines, severe stroke, or traumatic brain injury.
- •Taking medications with significant psychotropic effects.
- •Severe sensory impairment.
- •Severe chronic illness where participation in the study could put participants at an unusual level of risk. Chronic conditions will be evaluated on a case by case basis as they arise.
- •Severe subjective cognitive concerns.
- •Requires a helper animal.
- •Has sufficient prior experience with neurostimulation that might unblind or alter the results.
- •Has metal or electronic implants that may be sensitive to stimulation or could interfere with stimulation or be an MRI contraindication, or has any other MRI contraindication.
- •Has sensitivity to components of tES electrodes being used (typically nickel or latex).
- •Feels ill or have any potential COVID-19 symptoms, such as fever or chills, cough, difficulty breathing, overly tired, unusual aches or pains including headache or sore throat, recent or unusual (for them) loss of taste or smell, congestion or runny nose, nausea or diarrhea.
- •Exclusion criteria for participants with MCI or AD:
- •Significant history of psychiatric disorders or current psychosis not related to a neurodegenerative condition.
- •Current excessive drug, alcohol or nicotine use.
- •Significant history of epilepsy, stroke, or traumatic brain injury.
- •Taking medications with significant psychotropic effects, not related to neurodegenerative condition
- •Severe sensory impairment
- •Severe chronic illness where participation in the study could put participants at an unusual level of risk. Chronic conditions will be evaluated on a case by case basis as they arise.
- •Requires a helper animal.
- •Has sufficient prior experience with neurostimulation that might unblind or alter the results.
- •Has metal or electronic implants that may be sensitive to stimulation or could interfere with stimulation.
- •Has sensitivity to components of tES electrodes being used (typically nickel or latex).
- •Feels ill or have any potential COVID-19 symptoms, such as fever or chills, cough, difficulty breathing, overly tired, unusual aches or pains including headache or sore throat, unusual loss of taste or smell, or unusual (for them) congestion or runny nose, nausea or diarrhea.
结局指标
主要结局
Learning Task Performance
时间窗: Within one hour after treatment
Performance accuracy on a complex visual learning and categorization task after full-current tES in comparison to partial-current tES.
次要结局
未报告次要终点
研究者
研究点 (2)
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