Effects of a Combined TMS and Cognitive Training in Alzheimer Patients: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
研究概览
简要总结
This study looks at the potential benefits of combining cognitive training (mental exercises) together with transcranial magnetic stimulation (also known as TMS) to see if this can make a difference in the condition of people with Alzheimer's disease by improving their disease and the cognitive decline that goes along with it.
详细描述
This study takes place in Boston, Massachusetts and Beth Israel Deaconess Medical Center. The treatment portion of the study requires patients to visit the BIDMC daily, Monday through Friday, for 6 weeks. All participants will receive real cognitive training, but half of our participants will receive active TMS treatment and half will receive a placebo TMS treatment. However, those receiving the placebo treatment will be offered the real treatment upon the completion of the study. This study goes up to approximately 4.5 months.
TMS is a noninvasive way of stimulating the brain, which is not painful and does not involve any needles or any form of surgery. It acts by delivering a magnetic stimulation to a particular region of your brain and that, coupled with the cognitive training, is what is being looked at in this study. The investigators are examining if this combination of TMS and cognitive training will improve your memory function and other mental functions such as language, orientation, and thinking or judgment.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age 55-90
- •Diagnosed with mild to moderate AD according to DSM-IV criteria
- •Diagnosis of dementia of the Alzheimer's type according to the criteria established by the NINCDS-ADRDA
- •Normal or corrected normal ability to see and hear
- •Primary language is English
排除标准
- •IQ below 85
- •Any major structural abnormalities on MRI (eg. Infarction, intracerebral malformation)
- •Any symptoms of disease or abnormalities sufficient to cause memory impairment other than AD (eg. Normal pressure hydrocephalus, progressive supranuclear palsy)
- •Any functional psychiatric disorder (eg. Schizophrenia)
- •Chronic uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (eg. Cardiac malformation)
- •History of seizures, diagnosis of epilepsy
- •Metal implants excluding dental fillings or any of the following medical devices: pacemaker, implanted medication pump, vagal nerve stimulator, deep brain stimulator, TENS unit (unless removed completely for this study), cerebral spinal fluid shunt
- •Recent withdrawal from the following drugs: alcohol, barbiturates, benzodiazepines, meprobamate, chloral hydrate
结局指标
主要结局
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
时间窗: Pre treatment; 1 month post treatment
Assessment to measure the severity of all of the most important symptoms of Alzheimer's disease: loss of memory, language, praxis, and attention. The total scoring range is 0-70, with 0 representing the least impairment and 70 the most severe impairment. The results posted below represent a change in score from baseline. A positive change represents an improvement on the ADAS-Cog (change = 1 month score - baseline score).
次要结局
- Clinical Global Impression of Change (CGIC)(Pre-treatment, 1 month post treatment)
- Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL)(Pre-treatment, 1 month Post-treatment)
研究者
Alvaro Pascual-Leone
Professor of Neurology
Beth Israel Deaconess Medical Center