Non-invasive Brain Stimulation by Transcranial Pulse Stimulation as a Coadjunctive Treatment in Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Cognitive Functions
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled clinical trial; that will evaluate the effectiveness of the use of transcranial pulse stimulation in people living with Alzheimer's disease, coming from the Institute of Psychiatry (IPQ) of the Hospital das Clinicas, Faculty of Medicine, University of São Paulo, and the Institute of Physical Medicine and Rehabilitation (IMREA) at the Hospital das Clínicas, Faculty of Medicine, University of São Paulo.
Participants will be classified according to the stage of Alzheimer's disease, determined by a psychiatrist and neuropsychologists. A total of 50 volunteers will be randomized blindly. In addition to evaluating the clinical course and imaging examination, the use of scales that assess functional and cognitive disability will be used for the recruitment of volunteers. Volunteers will be randomized into two study groups, and will receive the intervention that will consist of ten sessions, held twice a week. The Storz Neurolith™ equipment (Storz Medical, Tagerwillen, Switzerland) will be used to administer transcranial pulse stimulation.
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
- Double (Care Provider, Outcomes Assessor)
盲法说明
Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals who have Alzheimer's disease will be selected;
- •Are aged ≥50 years;
- •Medical assistance provided by the psychiatry service at IPQ;
- •Who agree to participate after consent via the Informed Consent Term .
排除标准
- •Make regular use of anticoagulants;
- •Has skullcap failure, craniectomy without cranioplasty;
- •Have a diagnosis of brain neoplasms or any type of nodule in the brain region;
- •Have recent brain bleeds or a diagnosis of cerebral arteriovenous malformation;
- •Be diagnosed with a type of dementia other than Alzheimer's;
- •Have Mild Cognitive Impairment of the Elderly (MCI);
- •Have clinical changes that put the test at risk, such as severe cardiorespiratory disorders;
- •Has a severe cognitive disorder that makes it impossible to apply therapy or questionnaires;
- •It is clinically or socially impossible for the patient to attend IMREA for applications twice a week during the study period;
- •Those who disagree to participate after consent via the Informed Consent Term .
结局指标
主要结局
Cognitive Functions
时间窗: Baseline and up to one, three, six and twelve months from intervention
Cognitive functions, using Alzheimer's Disease Assessment Scale (ADAS-Cog)
次要结局
未报告次要终点