Efficacy and Safety Study:The Influence of Repetitive Transcranial Stimulation (r-TMS) Treatment on Motor and Cognitive Measurements in Patients With Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Unified Parkinson Disease Rating Scale (UPDRS)(Motor Part)
研究概览
简要总结
The purpose of this study is to test the effects of deep rTMS using the novel H-coil on the motor, affective and cognitive deficits in patients with Parkinson's disease (PD) and to establish its safety in this population.
详细描述
Study rational:We anticipate that reaching deeper brain layers and larger volume of activation with the novel H-coil may induce significantly better therapeutic effects in patients with PD and will pave the way for establishing a novel and effective treatment for this disorder.
Design:A prospective, double blind sham-controled study. No. of centers:1 One: Tel-Hashomer Medical Center, affiliated to Sackler school of Medicine, Tel -Aviv University, Israel.
Study Population:Forty patients with idiopathic PD, Hoehn and Yahr stages II to IV, on stable antiparkinsonian therapy, with partial response.
Study Duration:Two years
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PD patients aged 40 years or older, diagnosed as idiopathic PD according to the UK Brain Bank criteria, with Hoehn & Yahr stages II - IV while "off". Participants on antidepressants should be at least 2 months on stable therapy.
排除标准
- •Patients who have concomitant epilepsy, a history of seizure or heat convulsion or history of epilepsy in first degree relative.
- •Patients on neuroleptics.
- •Patients with dementia or any unstable medical disorder.
- •History or current hypertension.
- •History of head injury or neurosurgical interventions.
- •History of any metal in the head (outside the mouth).
- •Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps.
- •History of migraine or frequent or severe headaches.
- •History of hearing loss.
- •The presence of cochlear implants
- •History of drug abuse or alcoholism.
- •Pregnancy or not using a reliable method of birth control.
- •Participation in current clinical study or clinical study within 30 days prior to this study.
结局指标
主要结局
Unified Parkinson Disease Rating Scale (UPDRS)(Motor Part)
时间窗: 10-90 days
次要结局
- Clinical Global Impression of Severity (CGIS)(10-90 days)