The Effect of Dual-site Repetitive Transcranial Magnetic Stimulation on Freezing of Gait in Patients With Parkinson Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Changes of Freezing of Gait Questionnaire
研究概览
简要总结
This study is a double-blinded randomized study examining the effectiveness of the dual-site repetitive transcranial magnetic stimulation on Freezing of Gait (FOG) in patients with Parkinson's disease. The investigators hypothesize that treatment using magnetic stimulation on double site (including M1-LL and SMA) 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-site high frequency rTMS over the bilateral primary motor cortex of the lower leg and supplementary motor area, whereas patients in the Active Comparator group underwent ten sessions of single-site active magnetic stimulation with high 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. Assessments of FOG, gait function, motor symptoms, excitability of cortex motor (using transcranial magnetic stimulation), plasma indicators and multimodal magnetic resonance were performed three times: at baseline, one day post intervention, one month post intervention, six 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
- •Idiopathic Parkinson's disease (PD), as diagnosed by a neurologist.
- •Item 3 of the Freezing of Gait Questionnaire(FOG-Q) scored ≥
- •Age between 40 and 80 years old.
- •Mini-Mental State Examination score >
- •Ability to walk 30 meters independently.
- •Stable medication.
- •Patients experienced FOG during an interview.
排除标准
- •Other neurological or psychiatric disorders.
- •Severe personality disorder. History of epilepsy, seizures, or convulsions.
- •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.
- •Severe dyskinesia, tremor, cognitive, visual or auditory impairment.
- •Patients who could not complete the follow-up.
结局指标
主要结局
Changes of Freezing of Gait Questionnaire
时间窗: Assessed at baseline, one day post intervention, one month post intervention, six months 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. The differences in FOG-Q scores before and after treatment can be used to evaluate the effect of TMS treatment.
次要结局
- Cortical silent period (CSP)(Assessed at baseline, one day post intervention)
- Short-interval intracortical inhibition (SICI)(Assessed at baseline, one day post intervention)
- Intracortical facilitation (ICF)(Assessed at baseline, one day post intervention)
- Short-interval intracortical facilitation (SICF)(Assessed at baseline, one day post intervention)
- Plasma indicators(Assessed at baseline, one day post intervention)
- Changes of MDS-UPDRS(Assessed at baseline, one day post intervention, one month post intervention, six months post intervention)
- Gait speed(Assessed at baseline, one day post intervention, one month post intervention, six month post intervention)
- Stride length(Assessed at baseline, one day post intervention, one month post intervention, six month post intervention)
- Stride time variability(Assessed at baseline, one day post intervention, one month post intervention, six month post intervention)
- Double support(Assessed at baseline, one day post intervention, one month post intervention, six month post intervention)
- Brian structure compared among groups(Assessed at baseline, one day post intervention, six month post intervention)
- Resting motor threshold (RMT)(Assessed at baseline, one day post intervention)
- Changes in functional connectivity in the brain cortex(Assessed at baseline, one day post intervention, six month post intervention)
- Changes in cerebral blood flow in the brain cortex(Assessed at baseline, one day post intervention, six month post intervention)
研究者
Kezhong Zhang
Professor/Chief physician
The First Affiliated Hospital with Nanjing Medical University