The Effect of Multi-target Magnetic Stimulation on Freezing Gait in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Changes of Freezing of Gait Questionnaire (FOG-Q)
研究概览
简要总结
This study is a double-blinded randomized study examining the effectiveness of the multi-target magnetic stimulation treatment on Freezing of Gait (FOG) phenomenon in patients with Parkinson's disease. We hypothesize that treatment using magnetic stimulation on motor cortex combined with spinal cord will improve FOG and gait symptoms in patients with Parkinson's disease.
详细描述
Patients in the Experimental group underwent ten sessions of double active magnetic stimulation with low frequency repetitive transcranial magnetic stimulation (rTMS) over the bilateral primary motor cortex of the lower leg followed by low frequency repetitive magnetic stimulation over the spinal cord, whereas patients in the Active Comparator group underwent ten sessions of single active magnetic stimulation with low frequency rTMS over the bilateral primary motor cortex of the lower leg. In addition, patients in the Sham Comparator group underwent 10 sessions of double sham rTMS on motor cortex and spinal cord. Assessments of FOG, gait function, motor symptoms and excitability of primary motor cortex motor were performed three times: at baseline, one day post intervention, one month post intervention.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1.Idiopathic Parkinson's disease (PD), as diagnosed by a neurologist.
- •2.Item 3 of the Freezing of Gait Questionnaire(FOG-Q) scored ≥
- •3.Age between 40 and 80 years old.
- •4.Mini-Mental State Examination score >
- •5.Ability to walk 30 meters independently.
- •6.Stable medication.
- •7.Patients experienced FOG in both medication "on" and "off" states.
排除标准
- •1.Other neurological or psychiatric disorders.
- •2.Severe personality disorder.History of epilepsy, seizures, or convulsions.
- •3.History of head injury or stroke.
- •4.Metal remains of the skull or inside the brain (outside the oral cavity).
- •5.Surgeries including metallic implants or known history of metal particles in the eye, pacemakers,hearing devices transplantation, or medical pumps.
- •6.Severe dyskinesia, termor, cognitive, visual or auditory impairment.
- •7.Patients who could not complete the follow-up.
结局指标
主要结局
Changes of Freezing of Gait Questionnaire (FOG-Q)
时间窗: Assessed at baseline, one day post intervention, one month post intervention
The Freezing of Gait questionnaire will be used to quantify the frequency and severity of this symptom. The score will be compared to the baseline. The minimum and maximum values of the FOG-Q are 0 and 24. A higher FOG-Q score means a worse outcome.
次要结局
- Gait speed(Assessed at baseline, one day post intervention, one month post intervention)
- Stride length(Assessed at baseline, one day post intervention, one month post intervention)
- MEP amplitude at 120% RMT intensity (AMP)(Assessed at baseline, one day post intervention.)
- Cortical silent period (CSP)(Assessed at baseline, one day post intervention.)
- The motor part of the Unified Parkinson's Disease Rating Scale(Assessed at baseline, one day post intervention, one month post intervention)
- Short-interval intracortical inhibition (SICI)(Assessed at baseline, one day post intervention.)
- Intracortical facilitation (ICF)(Assessed at baseline, one day post intervention.)
- Stride time variability(Assessed at baseline, one day post intervention, one month post intervention)
- Double support(Assessed at baseline, one day post intervention, one month post intervention)
- Resting motor threshold (RMT)(Assessed at baseline, one day post intervention.)
研究者
Kezhong Zhang
professor
The First Affiliated Hospital with Nanjing Medical University