The Effects of Repetitive Transcranial Magnetic Stimulation and Aerobic Exercise on Cognition, Balance and Functional Brain Networks in Patients With Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Functional Magnetic Resonance Imaging
研究概览
简要总结
Objectives: The purpose of this study was to investigate the effects of high-frequency repetitive Transcranial Magnetic Stimulation (rTMS) in Alzheimer's Disease (AD).
Methods: Twenty-seven AD patients aged ≥60 years were included in the study and divided into 3 groups (rTMS, Aerobic Exercise (AE) and control). All groups received pharmacological treatment. rTMS group (n=10) received 20 Hz rTMS treatment on bilateral dorsolateral prefrontal cortex, 5 days a week over 2 weeks, and AE group (n=10) received the moderate-intensity aerobic exercise for 50 min sessions, 5 days a week over 2 weeks. Control group (n=10) was only treated pharmacologically. Neuropsychiatric and behavioral status, cognition, balance, functional mobility, and quality of life, and functional brain changes were evaluated before and after the treatment.
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
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •having clinical AD diagnosis according to the NINCDS-ADRDA (National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association) criteria
- •being 60 years and older
- •having Clinical Dementia Rating Scale (CDR) scores 1 or 2
- •living independently
排除标准
- •not being able to walk independently,
- •having physical disabilities,
- •having a history of alcohol / substance abuse,
- •having head trauma
- •having epileptic seizures
研究组 & 干预措施
TMS group
In the TMS group (n=10) rTMS was applied to the bilateral dorsolateral prefrontal cortex (DLPFC) at 20 Hz, for 5 consecutive days per week for over 2 weeks (totally 10 sessions) in addition to the pharmacological treatment.
干预措施: Repetitive Transcranial Magnetic Stimulation (Device)
TMS group
In the TMS group (n=10) rTMS was applied to the bilateral dorsolateral prefrontal cortex (DLPFC) at 20 Hz, for 5 consecutive days per week for over 2 weeks (totally 10 sessions) in addition to the pharmacological treatment.
干预措施: Acetylcholinesterase Inhibitors (Drug)
TMS group
In the TMS group (n=10) rTMS was applied to the bilateral dorsolateral prefrontal cortex (DLPFC) at 20 Hz, for 5 consecutive days per week for over 2 weeks (totally 10 sessions) in addition to the pharmacological treatment.
干预措施: Memantine (Drug)
AE group
AE group (n=9) received a moderate- intensity aerobic exercise program lasting 50 minutes per session, 5 consecutive days per week for over 2 weeks (totally 10 sessions) in addition to the pharmacological treatment.
干预措施: Aerobic Exercise (Other)
AE group
AE group (n=9) received a moderate- intensity aerobic exercise program lasting 50 minutes per session, 5 consecutive days per week for over 2 weeks (totally 10 sessions) in addition to the pharmacological treatment.
干预措施: Acetylcholinesterase Inhibitors (Drug)
AE group
AE group (n=9) received a moderate- intensity aerobic exercise program lasting 50 minutes per session, 5 consecutive days per week for over 2 weeks (totally 10 sessions) in addition to the pharmacological treatment.
干预措施: Memantine (Drug)
Control group
No additional intervention was given to the patients in the control group (n=8) and participants were only treated pharmacologically.
干预措施: Acetylcholinesterase Inhibitors (Drug)
Control group
No additional intervention was given to the patients in the control group (n=8) and participants were only treated pharmacologically.
干预措施: Memantine (Drug)
结局指标
主要结局
Functional Magnetic Resonance Imaging
时间窗: 4 weeks after baseline
Resting state networks and activation areas in the brain were evaluating with Functional Magnetic Resonance Imaging
次要结局
- Timed Up and Go Test(4 weeks after baseline)
- Frontal Behavioral Inventory(4 weeks after baseline)
- Neuropsychometric test battery(4 weeks after baseline)
- Mini Mental State Examination Test(4 weeks after baseline)
- Neuropsychiatric Inventory Questionnaire(4 weeks after baseline)
- Quality of Life in Alzheimer's Disease Scale(4 weeks after baseline)
- Berg Balance Scale(4 weeks after baseline)
研究者
Miray Budak
Principal Investigator
Istanbul Medipol University Hospital