Investigating the Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) as a Treatment for Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) change
研究概览
简要总结
The main objective of this study is to investigate the effects of repetitive Transcranial Magnetic Stimulation (rTMS) treatment on patients with probable early or moderate Alzheimer's disease.
详细描述
Upon meeting the inclusion criteria and providing informed consent, each participant will complete a series of cognitive assessments and rTMS treatments at the TMS Lab at Riverview Health Center (PE-450).
After enrollment, patients at each site will be assigned using stratified block randomization into either active or sham treatment arms with different duration of treatment (either 2 weeks or 4 weeks).
rTMS at frequency of 20 Hz will be used to stimulate the dorsolateral prefrontal cortex (DLPFC) of each patient in the real groups. Prior to the first treatment, and once per week during treatment, the patient's motor threshold will be measured using single pulses of TMS, noting the intensity necessary to cause a small twitch in the thumb finger. Then, the 70 mm cooled coil will be placed on the head at a location for optimal stimulation of the DLPFC at an intensity of 90-100% of the motor threshold. The 20 Hz rTMS treatment will incorporate 30 pulses per train, with 25 trains per side of the brain per session (total of 750 pulses per side per session). The trains will have a duration of 1.5 seconds, with an intertrain interval of 10 seconds. Each TMS treatment session will take approximately 10 to 25 minutes.
The DLPFC will be located on each patient using our Brainsight neuronavigation system from a reference MRI scan. If we cannot retrieve a valid previous clinical MRI scan or a valid ordered research MRI scan, a reference head model will approximate the patient's anatomy.
The treatments will be administered daily (5 days/week) either for 4 weeks or 2 weeks. The same protocol will also be used while doing sham 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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) change
时间窗: Weeks 0 and 5
Standard measure of cognitive symptoms, a popular tool that measures the severity of dementia symptoms. The primary outcome measure will be the change in the score from the baseline at 5 weeks.
次要结局
- Verbal Fluency Test (VFT)(Weeks 0, 3, 5, 11, 19, and 27 for the 2 week group and weeks 0, 3, 5, 13, 21, and 29 for the 4 week groups)
- Neuropsychiatric Inventory-Questionnaire (NPI-Q)(Weeks 0, 3, 5, 11, 19, and 27 for the 2 week group and weeks 0, 3, 5, 13, 21, and 29 for the 4 week groups)
- Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)(Weeks 0, 3, 5, 11, 19, and 27 for the 2 week group and weeks 0, 3, 5, 13, 21, and 29 for the 4 week groups)
- Clinical Dementia Rating (CDR) sum of boxes(Week 27 for the 2 week group and week 29 for the 4 week group)
- Digit Span Test(Weeks 0, 3, 5, 11, 19, and 27 for the 2 week group and weeks 0, 3, 5, 13, 21, and 29 for the 4 week groups)
- Zarit Burden Interview (ZBI)(Weeks 0, 3, 5, 11, 19, and 27 for the 2 week group and weeks 0, 3, 5, 13, 21, and 29 for the 4 week groups)
- Stroop Test(Weeks 0, 3, 5, 11, 19, and 27 for the 2 week group and weeks 0, 3, 5, 13, 21, and 29 for the 4 week groups)
- Treatment Satisfaction Questionnaire for Medication (TSQM)(Weeks 3, 5, 11, 19, and 27 for the 2 week group and weeks 0, 3, 5, 13, 21, and 29 for the 4 week groups)
- Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) effect over time(Weeks 0, 3, 11, 19, and 27 for the 2 week group and weeks 0, 3, 13, 21, and 29 for the 4 week groups)
- Semantic Fluency Test (SFT)(Before and immediately after rTMS intervention in Week 1, at weeks 5 and 11 for the 2 week group and before and immediately after rTMS intervention in Week 1, at weeks 5, and 13 for the 4 week groups)