The Effect of Low-frequency Repetitive Transcranial Magnetic Stimulation on Motor Function in Patients With Parkinson's Disease (PD) With Freezing of Gait (FOG).
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes in frequency and severity of the freezing of gait phenomenon
研究概览
简要总结
This study is a double blind comparative study examining the effectiveness of the rTMS treatment on Freezing of Gait (FOG) phenomenon in patients with Parkinson's disease. We hypothesize that treatment using rTMS stimulation on frontal lobe areas will improve gait quality and decrease the frequency of FOG in patients with Parkinson's disease.
详细描述
A course of low-frequency repetitive transcranial magnetic stimulation (rTMS) delivered over the supplementary motor area (SMA) improves motor symptoms in patients with Parkinson's disease (PD).
The present study is a comparative study that examines the effectiveness of rTMS treatment technique Freezing of Gait (FOG) phenomenon in Parkinson's disease patients. We hypothesize that treatment using rTMS stimulation on frontal areas will decreasing frequency of FOGs in patients with Parkinson's disease and improve gait quality and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic Parkinson's disease (PD), as diagnosed by a neurologist.
- •The mini-mental state examination questionnaire score above 24 points.
- •Suffer from a disabling phenomenon called Freezing of Gait (FoG) (Freezing Of Gait questionnaire score> = 10)
- •Negative responses to the Preliminary Safety Magnetic Stimulation Treatment questionnaire.
排除标准
- •Other neurological or psychiatric disorders.
- •Severe personality disorder.
- •High Blood Pressure.
- •History of epilepsy, seizures or convulsions.
- •History of epilepsy or convulsions in first-degree relatives.
- •History of head injury or stroke.
- •Metal remains of the skull or inside the brain (outside the oral cavity).
- •Surgeries including metallic implants or known history of metal particles in the eye, pacemakers, hearing devices transplantation, or medical pumps.
- •Current history of migraines for the last six months.
- •A history of drug or alcohol abuse
- •Other medical research in the time to experiment or three months ahead. -
研究组 & 干预措施
rTMS treatment followed by Sham
A course of low-frequency repetitive transcranial magnetic stimulation (rTMS) delivered over the supplementary motor area (SMA) followed by rTMS maintenance period (1 month) and followed by sham treatment in order to show the efficacy of treatment
干预措施: Low-frequency repetitive Transcranial Magnetic Stimulation (Device)
rTMS treatment followed by Sham
A course of low-frequency repetitive transcranial magnetic stimulation (rTMS) delivered over the supplementary motor area (SMA) followed by rTMS maintenance period (1 month) and followed by sham treatment in order to show the efficacy of treatment
干预措施: rTMS maintenance (Device)
rTMS treatment followed by Sham
A course of low-frequency repetitive transcranial magnetic stimulation (rTMS) delivered over the supplementary motor area (SMA) followed by rTMS maintenance period (1 month) and followed by sham treatment in order to show the efficacy of treatment
干预措施: Sham (Device)
rTMS treatment followed by Sham
A course of low-frequency repetitive transcranial magnetic stimulation (rTMS) delivered over the supplementary motor area (SMA) followed by rTMS maintenance period (1 month) and followed by sham treatment in order to show the efficacy of treatment
干预措施: Sham maintenance (Device)
Sham treatment followed by rTMS
A course of sham followed by followed by sham maintenance period (1 month) and than followed by low-frequency repetitive transcranial magnetic stimulation (rTMS) delivered over the supplementary motor area (SMA) in order to show the effectiveness of rTMS
干预措施: Low-frequency repetitive Transcranial Magnetic Stimulation (Device)
Sham treatment followed by rTMS
A course of sham followed by followed by sham maintenance period (1 month) and than followed by low-frequency repetitive transcranial magnetic stimulation (rTMS) delivered over the supplementary motor area (SMA) in order to show the effectiveness of rTMS
干预措施: rTMS maintenance (Device)
Sham treatment followed by rTMS
A course of sham followed by followed by sham maintenance period (1 month) and than followed by low-frequency repetitive transcranial magnetic stimulation (rTMS) delivered over the supplementary motor area (SMA) in order to show the effectiveness of rTMS
干预措施: Sham (Device)
Sham treatment followed by rTMS
A course of sham followed by followed by sham maintenance period (1 month) and than followed by low-frequency repetitive transcranial magnetic stimulation (rTMS) delivered over the supplementary motor area (SMA) in order to show the effectiveness of rTMS
干预措施: Sham maintenance (Device)
结局指标
主要结局
Changes in frequency and severity of the freezing of gait phenomenon
时间窗: One week post intervention
The new version of the Freezing of Gait questionnaire will be used to quantify the frequency and severity of this symptom. The score will be compared to baseline.
次要结局
- Immediate changes in blood pressure(Every session, immediately after receiving the treatment)
- Community ambulation(One week post intervention)
- Changes in endurance(One week post intervention)
- Balance(One week post intervention)
- Immediate change in gait function(One week post intervention)
研究者
michal roll
Director of the R&D division in the Tel Aviv Sourasky Medical Center (TASMC)
Tel-Aviv Sourasky Medical Center