Research Study Evaluating Patient Experience With the MemorEM for Patients With Neurological Diseases
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Patient and caregiver reports on device design and use
研究概览
简要总结
Primary Objective:
The primary objective of this pilot study is to gain voluntary feedback from patients with neurological diseases and their caregivers regarding their experiences using the MemorEM head device. This information may help in new designs of the MemorEM and suggest ways to increase compliance for future clinical trials and eventual commercialization.
Secondary Objective:
The secondary objective is to note areas of potential improvement in the progression of the subject's neurological disease and identify the potential for the MemorEM to treat neurological diseases other than Alzheimer's disease. The investigators are also interested in Alzheimer's variants like those with ApoE4 alleles (none of the participants in the 8-person pilot were Apo-E4 positive), known mutations causing early onset Alzheimer's, and Posterior Cortical Atrophy.
详细描述
Study Duration:
The study will be open-ended with patients continuing use of the MemorEM as they wish or when NeuroEM Therapeutics recalls the device. It is expected but optional that patients will use the devices for approximately two years.
Study Design:
This study will focus on the "patient experience" of using the MemorEM device over an extended time period. Patients will remain under the care of their physicians and will provide brief descriptions of their device experiences and any suggestions for improvements. This study will not require any interventions other than using the MemorEM device, which was rated as Non-Significant Risk by the Western IRB for the previous pilot trial including two extensions that raised no safety concerns over the two and a half years of treatment.
Study Population:
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
- 45 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient diagnosed with a neurological disease involving aggregated proteins such as Alzheimer's and its variants, Parkinson's, Frontotemporal dementia, Amyotrophic lateral sclerosis, Tauopathies, and other related neurological diseases.
- •Presence of a caregiver(s) responsible for ensuring treatment compliance and potentially with authority to make medical decisions for the patient if the patient is not competent to make those decisions.
- •A statement from each patient's physician that indicates the patient has the ability to understand and consent on their own AND they have the willingness to sign CareONE's patient consent.
排除标准
- •Patient has Seizures, Epilepsy, uncontrolled Depression, uncontrolled Bipolar disorder, psychotic disorders, alcoholism or drug addiction
- •Presence of metal implants in the head, except for metal dental implants
- •Patient has hypertension that is unresponsive to anti-hypertensive medications
- •Patient has implanted medication pumps unless cleared by physician
- •Patient has significant heart disease, as determined by a physician
研究组 & 干预措施
Patient Experience Arm
干预措施: MemorEM (Device)
结局指标
主要结局
Patient and caregiver reports on device design and use
时间窗: Surveys will be given starting a month after beginning treatment and monthly thereafter over the course of up to two years.
The primary objective of this pilot study is to gain voluntary feedback from patients with neurological diseases and their caregivers regarding their experiences using the MemorEM head device. This information will be gathered via a monthly survey. This information may help in new designs of the MemorEM and suggest ways to increase compliance for future clinical trials and eventual commercialization.
次要结局
- Reports of efficacy in treating a patient's neurological condition(Surveys will be given starting a month after beginning treatment and monthly thereafter over the course of up to two years.)