NCT01825317已完成不适用
Effect of NeuroAD, Combined TMS Stimulation and Cognitive Training, on the Cognitive Function of Mild to Moderate Alzheimer Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Neuronix Ltd
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- ADAS-Cog
研究概览
简要总结
Non-invasive stimulation of the brain using magnetic and cognitive stimulation by computer for the treatment of Alzheimer patients.
详细描述
Synchronized TMS and cognitive training for the treatment of mild to moderate Alzheimer's patients. Treatment is delivered 5 days a week, for 6 weeks, visit is about an hour long.
Evaluation is by neuropsychological evaluation at 6 weeks.
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
- 60 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 60-90 years
- •Patients diagnosed with mild or moderate stage of Alzheimer's Disease, according to the DSM-IV criteria.
- •MMSE score 18 to 26
- •Adas-cog above 17
- •Physically acceptable for the study as confirmed by medical history and exam.
- •Spouse, family member or professional caregiver agree and capable of taking care and be responsible for the participation of the patient in the study (answering questions regarding the patient's condition and assuming responsibility for medication)
- •Agreement to participate in approximately 14 weeks during the study.
- •Normal or corrected to normal ability to see and to hear.
- •Korean as primary language
- •8th grade education minimum
排除标准
- •Severe agitation;
- •Mental retardation;
- •Patient lacking capacity to consent to study participation
- •Unstable medical condition;
- •Use of benzodiazepines or barbiturates during the study and preceding two weeks;
- •Pharmacological immunosuppression;
- •Participation in a clinical trial with any investigational agent within two weeks prior to study enrollment;
- •History of Epileptic Seizures or Epilepsy;
- •Contraindication for performing MRI scanning;
- •Contraindication for receiving TMS treatment according to a TMS questionnaire;
- •Pregnant women, and women who have the ability to become pregnant unless they are on an acceptable method of contraception during the study.
- •Patients with personal history of any clinically defined neurological disorder, including organic brain disease, epilepsy, stroke, brain lesions, or multiple sclerosis; or personal history of previous neurosurgery or head trauma that resulted in loss of consciousness.
- •Patients with depression, bipolar disorder or psychotic disorders or any other neurological or psychiatric condition (whether now or in the past), which the Investigator finds as interfering with the study
- •Alcoholism or drug addiction as defined by DSM-IV within last 5 years (addicted more than one year and or in remission less than 3 years) or severe sleep deprivation
- •Patients treated with cholinesterase inhibitors, or memantine or Ginko-biloba will be allowed to participate, if the treatment has started at least 6 months previous to recruitment. The patients should keep their dose of medication during the whole trial as prior to study begin.
- •Patients with metal in the head, except the mouth (i.e. cochlear implants, implanted brain stimulators, aneurysm clips)
- •Patients with increased intracranial pressure
- •Cardiac pacemakers
- •Implanted neurostimulators
- •Implanted medication pumps
- •Intracardiac lines
- •Significant heart disease
- •Currently taking medication that lower the seizure threshold
- •Significant sleep deprivation and alcoholism
研究组 & 干预措施
NeuroAD
Active Comparator
Treatment by the NeuroAD device, real treatment by synchronized TMS+cognitive training
干预措施: NeuroAD (Device)
Sham NeuroAD
Sham Comparator
Sham TMS+cog, has the same sound and appearance, patients come for the same number of treatments and are exposed to the same procedure.
干预措施: Sham device (Device)
结局指标
主要结局
ADAS-Cog
时间窗: 6 weeks
Alzheimer's disease assessment scale - cognitive test
次要结局
未报告次要终点
研究者
研究点 (1)
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