NCT07600320尚未招募不适用
Microtesla Magnetic Therapy (MMT) Treatment of Cognitive Impairment: Open Label Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to assess the safety and feasibility of an at-home MMT treatment in patients with cognitive dysfunction related to acquired brain injury, Long COVID, traumatic brain injury, myalgic encephalomyelitis (ME/CFS), and other neurodegenerative diagnoses including but not limited to Alzheimer's disease and to collect data on safety and efficacy to inform the design of larger clinical studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IncInclusion Criteria:
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Any sex/gender
- •16 years of age or older
- •English Speaking
- •Experiencing symptoms of at least self-reported mild cognitive impairment associated with a confirmed diagnosis of a condition such as Long COVID, Traumatic Brain Injury, other Acquired Brain Injuries, and other neurodegenerative diagnoses including but not limited to Alzheimer's disease
- •Individuals of childbearing age agreeing to use a highly effective form of birth control for the duration of their participation
- •Willing and able to sign informed consent or have a parent or LAR able to sign informed consent form
- •Willing and able to attend all study visits virtually or in person
排除标准
- •Individual who meets any of the following criteria will be excluded from participation in this study:
- •Enrollment in another interventional clinical trial in the last 90 days or during the study period
- •Change in anti-depressant or other psychoactive medication or dose in the last 90 days
- •Cranially implanted devices or metal
- •Pacemaker
- •History of seizure disorder
- •Pregnant or plan to become pregnant during the study as indicated by proof of a positive pregnancy test
- •Inability to achieve appropriate positioning of the study device on the head
- •Any medical, psychiatric, or neurological condition, or concurrent treatment, that in the opinion of the Principal Investigator would interfere with study participation, interpretation of results, or pose additional risk to the participant.
研究者
David Putrino
Professor
Icahn School of Medicine at Mount Sinai
研究点 (1)
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