NCT04562506已完成不适用
Repetitive Transcranial Magnetic Stimulation With H-coil in Alzheimer's Disease: A Double-blind, Placebo-controlled Pilot Study
Giancarlo Comi2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年10月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Improvement at Alzheimer's Disease Assessment Scale-cognitive over time
研究概览
简要总结
Focal repetitive transcranial magnetic stimulation (rTMS) has been applied to improve cognition in Alzheimer's disease (AD) with conflicting results. In this study we aimed to explore feasibility, safety and efficacy of excitatory rTMS of bilateral DLPFC applied with H-coil in AD in a pilot randomized, placebo-controlled, double-blind study.
详细描述
Study Design The study was a double-blind, placebo-controlled paradigm, with randomization into a real rTMS group or a sham rTMS
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand the purpose and risk of the study and provide signed and dated informed consent.
- •Male or female subjects, 18 to 80 years old.
- •Diagnosis of Alzheimer's disease according to the DSM IV
- •Subjects who answered all questions in the TMS pre-treatment safety questionnaire in a negative manner.
- •Have given written informed consent
排除标准
- •Presence of an additional neurological or psychiatric pathology.
- •Severe personality disorder.
- •Uncontrolled hypertension.
- •History of epilepsy, seizures, febrile convulsions.
- •History of epilepsy or seizures in first degree relatives.
- •History of head injury or stroke.
- •Presence of metal prostheses in the head (except dental fillings).
- •Metal implants or known history of any metal particles in the eye, cardiac pacemakers, cochlear implants, use of neurostimulators or medical pumps.
- •History of migraine within the past six months.
- •History of drug or alcohol abuse.
- •Impossibility of adequate communication with the examiner.
- •Participation in another clinical study, either concomitant or within the previous 3 months.
- •Inability to sign the consent form.
结局指标
主要结局
Improvement at Alzheimer's Disease Assessment Scale-cognitive over time
时间窗: Change in the score between Baseline evaluation and end of the treatment (2 months after start of the treatment)
Brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia
次要结局
- Improvement at Mini Mental State Examination scale over time(Baseline evaluation, 1 month after start of the treatment, end of the treatment (2 months after start of the treatment) and end of follow-up (4 months after start of the treatment))
- Improvement at Clinical Global Impression-Improvement scale over time(Baseline evaluation, 1 month after start of the treatment, end of the treatment (2 months after start of the treatment) and end of follow-up (4 months after start of the treatment))
- Persistence of improvement at Alzheimer's Disease Assessment Scale-cognitive over time(Change in the score between end of treatment (2 months after start of the treatment) and end of follow-up (4 months after start of treatment))
- Improvement at Beck Depression Inventory scale-II over time(Baseline evaluation, 1 month after start of the treatment, end of the treatment (2 months after start of the treatment) and end of follow-up (4 months after start of the treatment))
研究者
Giancarlo Comi
MD
IRCCS San Raffaele
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Improving Neurocognitive Deficits and Function in Schizophrenia With Transcranial Magnetic StimulationSchizophreniaSchizoaffective DisorderNCT03037983VA Office of Research and Development9
已完成
不适用
Repetitive Transcranial Magnetic Stimulation With H-coil in Parkinson's Disease (rTMS-PD)Parkinson DiseaseNCT04638777Giancarlo Comi60
招募中
不适用
Effects of Repetitive Transcranial Magnetic Stimulation in Patients With Alzheimer's DiseaseAlzheimer DiseaseNCT06385106First Affiliated Hospital of Zhejiang University30
已完成
不适用
Repetitive Transcranial Magnetic Stimulation for DementiaMild Cognitive ImpairmentDementiaNCT02621424VA Office of Research and Development32
招募中
不适用
rTMS Treatment of Spasticity in Children With Cerebral Palsy/ Hemiplegia Due to ABI - a RCTCP (Cerebral Palsy)NCT06128746The University of Hong Kong20