Repetitive Transcranial Magnetic Stimulation With H-coil in Parkinson's Disease: A Double-blind, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change at Unified Parkinson's disease rating scale III over time
研究概览
简要总结
Focal repetitive transcranial magnetic stimulation (rTMS) has been applied to improve symptoms in Parkinson disease (PD) with conflicting results. However, the stimulation with H-coil has been shown to stimulate a wider cortical area compared with the standard coils, with preliminary results confirming the potential efficacy of the treatment. In this study the investigators aimed to explore the safety and efficacy of excitatory rTMS with H-coil on PD motor symptoms.
详细描述
This was a double-blind, placebo-controlled study, with a 1:1:1 randomization into three groups: group 1 - real rTMS over primary motor cortex and prefrontal cortex (M1-PFC): group 2 - real rTMS over M1 and sham rTMS over PFC; group 3 - sham stimulation over both targets
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
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged ≤80 years
- •Diagnosis of Parkinson's disease according to UK Brain Bank criteria
- •Hoehn and Yahr (HY) scale II-IV
- •Stable anti-depressive and anti-parkinsonian therapy for at least two months prior to enrollment
- •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
Change at Unified Parkinson's disease rating scale III over time
时间窗: Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment)
A comprehensive 50 question assessment of both motor and non-motor symptoms associated with Parkinson's
Incidence of Treatment-Emergent adverse events [Safety and Tolerability of rTMS]
时间窗: End of treatment (1 month after start of the treatment)
monitoring presence of side effects due to the stimulation
次要结局
- Change at Digit forward & backward test over time(Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment))
- Change at Tapping test over time(Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment))
- Change at Pegboard test over time(Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment))
- Change at and at Word Fluency test over time(Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment))
- Change at Up & Go Test over time(Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment))
- Change at dyskinesia rating scale over time(Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment))
- Change at Beck Depression Inventory scale-II over time(Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment))
- Change at The Clinical Global Impression - Severity scale ( CGI-S) over time(Baseline evaluation, end of treatment (1 month after start of the treatment) and end of follow-up (2 months after start of the treatment))
研究者
Giancarlo Comi
MD, Principal Investigator
IRCCS San Raffaele