Prospective, Randomized, Evaluator-blind, Single Center Study on the Effect of Transcranial Magnetic Stimulation in Mild to Moderate Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- the short term change of K-MMSE score in TMS group
研究概览
简要总结
The investigators will compare cognitition, mood (depression), ADL, and brain structural and functional MRI before and after 4-week transcranial magnetic stimulation in patients with mild to moderate Alzheimer's disease.
The investigators also compare the change of cognitition, mood (depression), ADL, and brain structural and functional MRI between TMS group and sham coil group.
详细描述
Each 16 patients will be allocated to TMS group and sham coil group. Before TMS/sham coil stimulation, the investigators will take fMRI of each patient, and figure out which focus has strongest connectivity to hippocampus among lateral parietal regions of the brain. The investigators will fix the TSM transduced and apply accurate TMS stimulation to the focus using personalized frames. The investigators will make the frame using 3D printing technology.
After 4 week- TMS stimulation, the investigators will compare cognitition, mood (depression), ADL, and brain structural and functional MRI beween baseline and after intervention. The investigators also compare the change of cognitition, mood (depression), ADL, and brain structural and functional MRI between TMS group and sham coil group.
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
- Single (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
- •patients who visited memory clinic of Samsung Medical Center
- •aged 55 ~ 90
- •diagnosed as probable Alzheimer dementia according to NIA-AA guideline 2011, or MCI patiens with amyloid PET positivity
- •below -1SD in SVLTdelayed recall test and RCFT delayed recall test
- •K-MMSE >=18
- •no epileptic discharge in EEG
- •no history of epilepsy
- •no arrhythmia or MI in ECG
- •can read and write Korean (literate)
- •volunteer and agree to the registration
排除标准
- •no other neurologic deficit which can cause dementia except for Alzheimer's disease
- •paitient who has severe cerebral white matter hyperintensities. (deep white matter >=2.5cm and caps or band >=1.0 cm)
- •patients with severe medical disease including caner and ishemic heart disease
- •claustrophobia or allergic to contrast of MRI
- •medical deviced which is not removable (e.g pacemaker, cochlear implantation, dental prosthesis)
- •history of brain surgery, and intervension or surgery of intra/extracranial artery(e.g. carotid artery stent insertion, CEA)
- •patient with dyspnea during resting
- •history of loss of consciousness for more than 1 hour except for general anesthesia
- •patients who cannot read written material because of poor visual acuity
- •patients who cannot communicate because of severe hearing difficulty
- •history of ototoxicity medication or exposure severe noises
- •determined as inapropriate to participate clinical trial
结局指标
主要结局
the short term change of K-MMSE score in TMS group
时间窗: 4 weeks
the short term change of K-MMSE (Korean version of mini mental status exam) score in TMS group
the short term change of COWAT score in TMS group
时间窗: 4 weeks
the short term change of COWAT(controlled oral word association) score in TMS group
the short term change of RVP score in TMS group
时间窗: 4 weeks
the short term change of RVP(raid visual information processing) score in TMS group
the short term change of TMT score in TMS group
时间窗: 4 weeks
the short term change of TMT(trail-making test) score in TMS group
the short term change of K-MoCA score in TMS group
时间窗: 4 weeks
the short term change of K-MoCA (Korean version of Montreal cognitive assessment) score in TMS group
the short term change of ADAS-Cog score in TMS group
时间窗: 4 weeks
the short term change of ADAS-Cog(the Alzheimer's disease assessment scale-cognitive subscale) score in TMS group
the short term change of Stroop score in TMS group
时间窗: 4 weeks
the short term change of Stroop score in TMS group
the short term change of SWM score in TMS group
时间窗: 4 weeks
the short term change of SWM (spatial working memory) score in TMS group
the short term change of PRM score in TMS group
时间窗: 4 weeks
the short term change of PRM(pattern recognition memory) score in TMS group
次要结局
- the long term change of COWAT score in TMS group(8 weeks)
- the change of brain structure in TMS group(4 weeks)
- the long term change of K-MMSE score in TMS group(8 weeks)
- the long term change of TMT score in TMS group(8 weeks)
- the change of ADL(activity of daily life) in TMS group(4 weeks)
- the comparison of short term change of SWM between TMS group and sham group(4 weeks)
- the long term change of Stroop score in TMS group(8 weeks)
- the long term change of ADAS-Cog score in TMS group(8 weeks)
- the long term change of RVP score in TMS group(8 weeks)
- the long term change of K-MoCA score in TMS group(8 weeks)
- the long term change of SWM score in TMS group(8 weeks)
- the long term change of PRM score in TMS(8 weeks)
- the short term change of mood (depression) in TMS group(4 weeks)
- the long term change of mood (depression) in TMS group(8 weeks)
- the comparison of short term change of K-MoCA score between TMS group and sham group(4 weeks)
- the comparison of short term change of CDR-SOB between TMS group and sham group(4 weeks)
- the comparison of short term change of RVP score between TMS group and sham group(4 weeks)
- the change of brain function in TMS group(4 weeks)
- the comparison of short term change of K-MMSE score between TMS group and sham group(4 weeks)
- the comparison of short term change of Stroop test score between TMS group and sham group(4 weeks)
- the comparison of short term change of PRM between TMS group and sham group(4 weeks)
- the comparison of long term change of K-MoCA between TMS group and sham group(8 weeks)
- the comparison of long term change of CDR-SOB between TMS group and sham group(8 weeks)
- the comparison of long term change of TMT score between TMS group and sham group(8 weeks)
- the comparison of long term change of cognitive function between TMS group and sham group(8 weeks)
- the comparison of short term change of ADAS-Cog between TMS group and sham group(4 weeks)
- the comparison of short term change of ADL between TMS group and sham group(4 weeks)
- the comparison of long term change of ADL between TMS group and sham group(8 weeks)
- the comparison of short term change of COWAT score between TMS group and sham group(4 weeks)
- the comparison of short term change of TMT between TMS group and sham group(4 weeks)
- the comparison of change of K-MMSE between TMS group and sham group(8 weeks)
- the comparison of short term change of mood (depression) between TMS group and sham group(4 weeks)
- the comparison of change of resting fMRI between TMS group and sham group(4 weeks)
- the comparison of long term change of COWAT score between TMS group and sham group(8 weeks)
- the comparison of long term change of stroop test score between TMS group and sham group(8 weeks)
- the comparison of long term change of RVP score between TMS group and sham group(8 weeks)
- the comparison of long term change of mood (depression) between TMS group and sham group(8 weeks)
- the comparison of change of FA value between TMS group and sham group(4 weeks)
- the comparison of long term change of ADAS-Cog between TMS group and sham group(8 weeks)
- the comparison of long term change of SWM score between TMS group and sham group(8 weeks)
研究者
Duk Lyul Na
Professor
Samsung Medical Center