NCT02249715Unknown不适用
Pilot Study for Development of a Monitoring Set-up and Algorithm Using Functional MRI (fMRI) and EEG for Prediction of Response to Repetitive Deep Transcranial Magnetic Stimulation (rDTMS) for Patients With Parkinson's Disease
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 主要终点
- Unified Parkinson's Disease Rating Scale (UPDRS)
研究概览
简要总结
- To characterize physiological biomarkers of positive response to rDTMS using EEG and functional MRI (fMRI) in patients with PD.
- To develop a set-up and algorithm for neurophysiological monitoring for PD patients using EEG and fMRI in patients treated by rDTMS.
- To integrate rDTMS stimulation with monitoring techniques with the ultimate goal of providing closed-loop feedback where monitoring informs the stimulation
详细描述
PD Patients aged 40 years or older, diagnosed as idiopathic PD according to the UK Brain Bank criteria will be treated by an established rDTMS protocol will be monitored before, during and after rDTMS using quantitative EEG and brain network analysis and fMRI while performing a series of cognitive and motor tasks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic PD patients aged 40-75 years;
- •Hoehn and Yahr stages II to IV
- •Patients on stable antiparkinsonian therapy for 1 month
- •Right hand dominance with right afflicted side.
排除标准
- •Participation in current clinical study or clinical study within 30 days prior to this study.
- •Subject has an atypical parkinsonian syndrome or secondary parkinsonism (e.g., due to drugs, metabolic neurogenetic disorders, encephalitis, cerebrovascular disease or other degenerative disease)
- •Patients with significant psychiatric symptoms or history.
- •Patients with psychotic symptoms or active depressive symptoms
- •Treatment with neuroleptics.
- •Beck depression inventory (BDI) score <14
- •Mini Mental status examination (MMSE) score <25
- •History of migraine or frequent or severe headaches.
- •Significant sensory deficits, e.g., deafness or blindness History of head injury or neurosurgical interventions.
- •Subjects who have concomitant epilepsy, a history of seizure/s, heat convulsions or history of epilepsy in first degree relative.
- •History of any metal in the head (outside the mouth).
- •The presence of cochlear implants
- •Known history of any metallic particles in the eye, implanted cardiac pacemaker, implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
- •Subjects with an unstable medical disorder.
- •Current drug abuse (including Cannabis) or alcoholism.
- •Pregnancy or not using a reliable method of birth control.
- •Patients with severe tremor or dyskinesia
结局指标
主要结局
Unified Parkinson's Disease Rating Scale (UPDRS)
时间窗: 3 month
次要结局
未报告次要终点
研究者
相似试验
已完成
不适用
Neuroimaging and Biomarkers in Chronic Visceral PainIrritable Bowel SyndromeNCT01602575University of California, Los Angeles119
终止
不适用
Brain Vital Signs M-Score: Point-of-care Monitoring for Motor Recovery After StrokeStrokeNCT03858699HealthTech Connex Inc.22
进行中（未招募）
2 期
RNS System LGS Feasibility StudyEpilepsyLennox Gastaut SyndromeLennox-Gastaut Syndrome, IntractableSeizuresSeizures, GeneralizedNCT05339126NeuroPace24
招募中
不适用
Stress Management with Real-time Bio-signal BiofeedbackBipolar Disorder (BD)Major Depressive DiorderNCT06616116Seoul National University Hospital100
已完成
不适用
Concurrent TMS and EEG Pilot StudyHealthyNCT05665634Johns Hopkins University24