A Double Blind Sham-controled Study to Evaluate the Influence of Low Frequency Repetitive Transcranial Stimulation (r-TMS) on Motor and Cognitive Measurements in Patients With Asymmetric Parkinson's Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Decrease in Unified Parkinson's Disease Rating Scale (UPDRS) score
研究概览
简要总结
The purpose of this study is to test the effects of low frequency deep rTMS using the novel H-coil on the motor, affective and cognitive deficits in patients with asymmetric Parkinson's disease (PD), to establish its safety in this population and to test effects of maintenance treatments.
详细描述
PD patients with asymmetric disease aged 40 years or older, diagnosed as idiopathic PD according to the UK Brain Bank criteria, with Hoehn & Yahr stages II - IV while "off" will be recruited. Participants on antidepressants should be at least 2 months on stable therapy.
Patient will be excluded if:
- 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 unstable medical disorder.
- History or current unstable 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, implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
- History of migraine or frequent or severe headaches.
- Current hearing loss.
- The presence of cochlear implants
- Current 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.
Patients will be to randomized to an active rTMS arm or to a sham stimulation arm. Each patient will be given 12 stimulation sessions, over a period of 4 weeks, and then a maintenance phase consisting of 8 stimulation sessions for the first 4 weeks and additional 4 stimulation sessions during the following 4 weeks.
Active treatment with the H-coil will include stimulation over the motor cortex (1 Hz stimulation 110% of the motor threshold for 15 minutes) and over the prefrontal cortex (10Hz stimulation 100% of the motor threshold, 2 seconds each train, 20 seconds between trains, for 15 minutes). The control arm group will receive sham stimulations in identical treatment and maintenance schedules. Patients from the sham group who will complete the study will be given the opportunity to receive 12 sessions of real r-TMS treatment over 4 weeks as the treatment 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PD patients with asymmetric disease 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 unstable medical disorder.
- •History or current unstable 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, implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
- •History of migraine or frequent or severe headaches.
- •Current hearing loss.
- •The presence of cochlear implants
- •Current 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
Decrease in Unified Parkinson's Disease Rating Scale (UPDRS) score
时间窗: 3 months
A decrease in the total UPDRS score in general and in the Motor UPDRS (part 3) score.
次要结局
- Increase in Digits Forward & Backwards test(3 months)
- CGIS(3 months)
- Increase in Tapping test(3 months)
- Decrease in time in Pegboard test(3 months)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(3 months)
- Decrease in Time Up&Go test(3 months)
- Increase in Word fluency(3 months)
研究者
Dr. Oren Cohen
MD
Sheba Medical Center