NCT04333329已完成不适用
Transcranial Pulse Stimulation for Alzheimer's Disease in an Open Prospective Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Adverse Device Effects
研究概览
简要总结
This is a prospective open comprehensive proof-of-principle pilot study.
详细描述
This is a prospective open comprehensive proof-of-principle pilot study with patients of mild to moderate Alzheimer's Disease who have been treated with transcranial pulse stimulation (TPS)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically stable patients with probable Alzheimer's Disease (Diagnosis according to ICD-10 Criteria (F00))
- •MMSE ≥ 10: Mild and moderate Alzheimer's Disease according to AWMF Register, S3 Guidelines of DGN 038/013 and DEGAM 035/021
- •At least 3 months of stable antidementia therapy or no antidementia therapy necessary (Patients need to continue their standard treatment within the clinical investigation according to the guidelines as TPS is considered an additional treatment to standard therapy)
- •Signed written informed consent
- •18 years ≤ Age ≤ 85 years
- •Monthly pregnancy tests for female patients in childbearing age
排除标准
- •Non-compliance with the protocol (including CERAD-plus)
- •Pregnancy
- •Breast-feeding women
- •Microbubbles (contrast agents) in application area
- •Cerebral pathology unrelated to Alzheimer's disease
- •Metallic objects in the head
- •Neurosurgical intervention of the brain / Craniotomy
- •Cardiac disorders
- •History of psychiatric diseases before development of dementia
- •Hemophilia or other blood clotting disorders
- •Cortisone treatment up to 6 months before first treatment
- •Other conditions implying increased risk according to the judgement of the investigator
结局指标
主要结局
Adverse Device Effects
时间窗: within 3 months follow-up
Number of ADEs
Consortium to Establish a Registry for Alzheimer's Disease (CERAD) - Total Score
时间窗: 3 months after treatment
CERAD is a cognitive test battery which is normalized for age, gender and education. The CERAD total score ranges from 0 to 100 with 100 meaning "normal cognitive ability" and 0 meaning "severe cognitive impairment".
次要结局
- Consortium to Establish a Registry for Alzheimer's Disease (CERAD) - Total Score(1 month after treatment (at 6 weeks))
- Beck Depression Inventory (BDI)(3 months after treatment (at 14 weeks))
- Geriatric Depression Scale - short form (GDS-15)(3 months after treatment (at 14 weeks))
- Mini-Mental-State Examination (MMSE)(3 months after treatment (at 14 weeks))
- Clock Drawing Test (CDT)(3 months after treatment (at 14 weeks))
研究者
研究点 (2)
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