A Pilot Randomized Placebo-Controlled Trial of Transcranial Pulse Stimulation (TPS) in Early Alzheimer's Disease (AD) Subjects
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale score.
研究概览
简要总结
TPS is a non-invasive therapeutic modality that uses focused, low-energy pulse stimulation to stimulate tissue regeneration and reduce inflammation. In the context of neurological disorders, it is hypothesized that TPS can modulate neuronal activity, enhance synaptic plasticity, and reduce neuroinflammation. It is a relatively new application in neurological disease treatment and is still under intense investigation.
详细描述
This pilot randomized placebo-controlled trial investigates the effects of transcranial pulse stimulation in subjects with early Alzheimer's Disease (AD). The TPS/Sham-TPS is administered for the first two weeks, followed by additional sessions at some week intervals. The transcranial pulse stimulation device used in this trial is a CE-certified medical instrument (ISO 9001 and ISO 13485).
The study aims to evaluate cognitive function, and neuropsychiatric symptoms using the some cognitive assessment tools, Frontal near-infrared spectroscopy (fNIRS), and fasting blood test at baseline at week 12.
This study is expected to lay the groundwork for future, larger-scale studies
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
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults who have been clinically diagnosed with Alzheimer's Disease in the early stage 2-6a according to the Functional Assessment Staging Test (In Appendix A)
- •The mental capacity to give informed consent for research is made by an experienced geriatrician based on Appendix A.
- •Aged 60-90 years old.
- •Able to make informed consent under assistance, which is witnessed and signed by a family caregiver.
排除标准
- •Cannot understand Chinese.
- •Mentally incapacitated, unable to provide informed consent
- •Inability to remain still for 30 minutes
- •Lack of available family caregiver to answer questionnaires
- •Alcohol or substance dependence
- •Major neurological conditions, including:
- •Brain tumor
- •Brain aneurysm
- •Presence of any metal implants in the brain
- •Hemophilia or other blood clotting disorders
- •History of thrombosis
结局指标
主要结局
Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale score.
时间窗: baseline（ 1st Week）； follow-up （ after finishing the TPS therapy at 12th week）
The lower the score, the better the cognitive function; the higher the score, the more severe the cognitive impairment. Score range: 0-85
次要结局
- Change in oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HbR) in the cerebral blood(baseline（ 1st Week）； follow-up （ after finishing the TPS therapy at 12th week）)
- Change in plasma Aβ42/40(baseline（ 1st Week）； follow-up （ after finishing the TPS therapy at 12th week）)
- Change in the Neuropsychiatric Inventory total score.(baseline（ 1st Week）； follow-up （ after finishing the TPS therapy at 12th week）)
- Change in the Animal Fluency Test score(baseline（ 1st Week）； follow-up （ after finishing the TPS therapy at 12th week）)
- Change in the Disability Assessment for Dementia total score.(baseline（ 1st Week）； follow-up （ after finishing the TPS therapy at 12th week）)
- Change in oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HbR) in the cerebral blood(baseline（ 1st Week）； follow-up （ after finishing the TPS therapy at 12th week）)
- Change in plasma Aβ42/40(baseline（ 1st Week）； follow-up （ after finishing the TPS therapy at 12th week）)
研究者
Timothy Kwok
Professor
Chinese University of Hong Kong