Transcutaneous Magnetic Spinal Cord Stimulation for Freezing of Gait in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- TUG
研究概览
简要总结
Dopaminergic drugs partially alleviate gait problems in Parkinson's disease, but the effects are not sustained in the long-term. Particularly, the freezing of gait, balance problems and other gait issues directly impacts patients' quality of life. Experimental epidural spinal cord stimulation studies have suggested positive effects on locomotion among PD patients, but the effects of non invasive stimulation have never been explored.
详细描述
The present study is a randomized, double-blind, placebo-controlled, parallel, phase II clinical trial that will assess the efficacy and safety of transcutaneous magnetic spinal cord stimulation in PD patients who have gait and balance changes refractory to dopaminergic therapy.
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, Investigator)
盲法说明
The random sequence will be generated by a computer program (randomization.com) using randomly exchanged blocks (size of four per block, active ratio / placebo 1: 1). Randomization will be stratified according to the severity of symptoms (TUG> 33 seconds = severe group; TUG ≤ 33 seconds = light group). The researchers will be specifically instructed not to break the randomization schedule in any way. Different researchers will carry out randomization, clinical evaluation and stimulation. Patients will be blinded to randomization.
入排标准
- 年龄范围
- 21 Years 至 81 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women (not pregnant) aged between 21 and 80 years old;
- •Participants with idiopathic Parkinson's disease in Hoehn Yahr stages between 2 and 4 (moderate disease) during off-medication, whose primary symptom includes change in gait and / or balance (score equal to or greater than 1 in subitem 2.12 of the MSD scale -UPDRS ["gait and balance"]). The participant must also present freezing (block) of gait (score equal to or greater than 1 in sub-item 2.13 of the MSD-UPDRS scale - "freezing"). Patients should experience the above symptoms even though they are optimized from the medication point of view. The criteria for being optimized will be defined by a neurologist specialized in movement disorders who will evaluate the case. The presence of freezing will be confirmed through a specific scale (FOG score).
- •Mini-examination of mental status greater than or equal to 24 points;
- •Able to give informed consent in accordance with institutional policies;
- •Able to meet all testing and monitoring requirements, as defined by the study protocol;
排除标准
- •Patients with unstabilized psychiatric comorbidities
- •Impossibility to consent to your participation in the study.
- •Patients with uncontrolled infection or other pre-existing uncontrolled medical conditions (eg, decompensated diabetes, high blood pressure, pneumo or symptomatic heart disease).
- •Concomitant treatment with other experimental drugs.
- •Pregnant or breastfeeding women.
- •Presence of chronic pain in the lower limbs.
- •Patients who are unable to walk without assistance (cane, crutch, walker) or help from another person when they are without their medications for Parkinson's disease (off-medication).
结局指标
主要结局
TUG
时间窗: Post-stimulation: immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.
The primary outcome will be the change in gait speed between pre-stimulation and post-stimulation conditions between the two groups (active and placebo) assessed using the 5-meter total Timed Up and Go Test (TUG). Mixel model ANOVA, with TUG as the dependent variable, and time and group as independent variables -'group' would have two levels ('active' and 'placebo'). Our alternative hypothesis is that 'the time vs. group' interaction effect is significant. Then we should use post hoc statistical tests to explore our data further and to compare the effects of active versus placebo at different time levels.
次要结局
- Secondary outcomes will be the effects of stimulation on other gait measures, step length, stride length and step width.(Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.)
- Secondary outcomes will be the effects of stimulation on other gait measures, cadencia.(Baseline, immediately after the fifth day of stimulation, seven days after finishing the stimulation, twenty-eight days after finishing the stimulation.)
- Secondary outcomes will be the effects of stimulation on balance after noninvasive magnetic stimulation of the dorsal spine in patients with parkinson's disease.(Baseline, seven days after finishing the stimulation, twenty-eight days after finishing the stimulation.)
- Secondary outcomes will be the change on other gait measures, gait speed.(Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.)
- Determination of possible adverse effects of noninvasive magnetic stimulation of the dorsal spine in patients with parkinson's disease.(Immediately after the fifth day of stimulation, seven days after finishing the stimulation, twenty-eight days after finishing the stimulation.)
- Assess the effects of transcutaneous magnetic stimulation of the dorsal cord on quality of life in patients with parkinson's disease(Baseline, seven days after finishing the stimulation, twenty-eight days after finishing the stimulation.)
- To evaluate the effects of noninvasive stimulation of the dorsal cord in the presence of freezing gait, through the application of questionnaires.(Baseline, immediately after the fifth day of stimulation, seven, fourteen, twenty-one and twenty-eight days after finishing the stimulation.)
- Assess the effects of transcutaneous magnetic stimulation of the spinal cord on the other motor symptoms of Parkinson's disease.(Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.)
- Assess the effects of transcutaneous magnetic stimulation of the spinal cord on cognition of Parkinson's disease.(Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.)