JPRN-jRCT2092220299已完成3 期
Double blinded study of high frequency repetitive transcranial magnetic stimulator for Parkinson's disease. - rTMS treatment study of Parkinson's disease
ihon Kohden Corporation0 个研究点目标入组 70 人开始时间: 2017年6月26日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
研究概览
简要总结
The safety of the rTMS treatment for Parkinson's disease has been confirmed. However, the efficacy of the rTMS treatment for motor symptoms and non-motor symptoms was not proven in this study.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Eligible patients are expected to meet all of the following criteria:
- •(1) PD patients diagnosed as Idiopathic PD based on the criteria of UK Parkinson's Disease Society brain bank
- •(2) PD patients whose symptoms are not considerably improved with L-dopa and/or dopamine agonist treatments, and also are at stage 2 to 4 in the modified Hoehn-Yahr Scale
- •(3) Patients who have been receiving a stable dosage of L-dopa and/or dopamine agonist at regular intervals for 4 weeks before rTMS treatment
- •(4) Patients who have been receiving a stable dosage of anticholinergic drugs, selegiline, entacapone, amantadine hydrochloride, droxidopa, zonisamide or istradefylline at regular intervals for 4 weeks before rTMS treatment
- •(5) Patients 20 years and older at time of providing informed consent
- •(6) In-patients or out-patients who can come to the hospitals where the study is conducted
- •(7) Patients who have voluntarily provided written consent for participation in this study, based on complete understanding our full explanation
排除标准
- •Patients meeting any of the following criteria are ineligible for this study:
- •(1) Patients exhibiting severe psychiatric symptoms such as severe hallucinations, delusion, confusion, abnormal behavior and so on, within 6 months (26 weeks) before the initiation of rTMS treatment
- •(2) Patients with drug or alcohol addiction (by ICD10 classification)
- •(3) Patients with less than a 24 score in mini-mental state examination at a screening
- •(4) Patients with less than a 11 score in UPDRS Part III at a screening
- •(5) Patients having a history of receiving surgical treatments (such as deep brain stimulation)
- •(6) Patients having taken medication listed below within 4 weeks of the initiation of rTMS treatment
- •+ dopamine receptor antagonistic antipsychotics (e.g. phenothiazines, butyrophenones, benzamides)
- •+ dopamine receptor antagonistic cardiovascular drugs (e.g. reserpine)
- •(7) Patients taking medication listed below currently or having taken it within 1 week of the initiation of rTMS treatment.
- •+ dopamine receptor antagonistic gastrointestinal drugs (e.g. metoclopramide and sulpiride, except for domperidone)
- •(8) Patients who have previously received rTMS treatment
- •(9) Patients with metal implants (e.g. clips, metals, and cochlear implant) in the head (except for oral implants)
- •(10) Patients having a cardiac pacemaker, implantable cardioverter defibrillators (ICD), vagal nerve stimulator or implantable drug infusion pump
- •(11) Patients with a large cerebral infarction, cerebral trauma, brain tumor, or epilepsy
- •(12) Patients having a malignant tumor, severe hepatic, renal, hematologic, respiratory, gastrointestinal or cardiovascular disease or metabolic or electrolyte imbalance. (Patients having a history of malignant tumors but being free of relapse for more than 5 years are allowed to be included. Severity criteria are based on grade 4 in Common Terminology Criteria for Adverse Events (CTCAE) v4.0.)
- •(13) Patients in whom no motor evoked potentials were elicited from the tibialis anterior muscle by TMS at the maximum stimulator output
- •(14) Patients who participated in other trials within 12 weeks before the date of providing informed consent for this study
- •(15) Pregnant patients or patients having a possibility of pregnancy. Patients who are breast feeding or attempting to become pregnant.
- •(16) Patients who were judged as ineligible by the principle investigator or subinvestigator
研究者
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