Effects of Magnetic Stimulation of the Dorsal Spinal Cord on Gait in Patients With Parkinson´s Disease and Deep Brain Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Timed Up and Go - Test 5 Meters (TUG-Test 5M)
研究概览
简要总结
Gait disorders are symptoms that significantly compromise the quality of life and functionality of patients with Parkinson's disease (PD). When they are not responsive to drug dopaminergic therapy and deep brain stimulation (DBS), the management of these symptoms is a challenge in clinical practice. Although deep brain stimulation is useful in the motor symptoms of Parkinson's disease, gait symptoms remains a challenge in patients undergoing this therapy. This is because, in addition to adjustments in the DBS programming not adding evident benefit in some patients with gait disorders, motor symptoms tend to progress over the years. In this context, spinal cord invasive electrical stimulation was proposed as a potential and effective therapy in a group of patients with PD who presented with gait impairment. More recently, the application of transcutaneous magnetic stimulation of the spinal cord has emerged as a possible therapeutic option, as it could stimulate neural elements in a non-invasive way. The general objective will be to study the effect of transcutaneous magnetic stimulation of the spinal cord on gait in PD patients with deep brain stimulation refractory to dopaminergic therapy. The method of the present study will be a randomized, double-blind, placebo-controlled, parallel, phase II clinical trial that will evaluate the efficacy of transcutaneous magnetic stimulation of the spinal cord in patients with PD and deep brain stimulation who present gait disorders refractory to dopaminergic therapy. 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 Timed Up and Go Test (TUG). Secondary outcomes will be the effects of stimulation on other gait measures (speed, step length, stride length, cadence, step width, sway time, support time and the presence of blocks), other motor symptoms (Unified Parkinson's Disease Rating Scale), cognitive alterations, quality of life and side effects. Statistical analysis will be performed using ANOVA for repeated measures and 38 patients will be included. The expected results are supported by transcutaneous magnetic stimulation of the spinal cord, which may improve gait disorders in participants with PD and DBS.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women (non-pregnant) aged between 21 and 80 years;
- •Presence of deep brain stimulation in the subthalamic nucleus or globus pallidus
- •Participants with idiopathic Parkinson's disease at Hoehn Yahr stages between 2 and 4 during off-medication, whose primary symptom includes altered gait and/or balance (score equal to or greater than 1 on sub-item 2.12 of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) ["gait and balance"]). Patients should present the above symptoms even though they are optimized from a drug point of view and with optimized programming. The criteria to be optimized will be defined by a neurologist specialized in movement disorders who will evaluate the case.
- •Able to give informed consent in accordance with institutional policies;
- •Able to meet all testing and follow-up requirements as defined by the study protocol
排除标准
- •Patients with unstabilized psychiatric comorbidities;
- •Impossibility to consent to their participation in the study;
- •Patients with uncontrolled infection or other uncontrolled pre-existing medical conditions (eg, decompensated diabetes, high blood pressure, symptomatic pneumo or heart disease);
- •Concurrent treatment with other experimental drugs;
- •Pregnant or breastfeeding women;
- •Patients who cannot walk, not even with unilateral aid of a walking aid device or another person, when they are without their medication for Parkinson's Disease (off-medication);
- •Presence of cardiac pacemaker.
研究组 & 干预措施
ACTIVE
Magnetic transcutaneous spinal cord stimulation
干预措施: Magnetic transcutaneous spinal cord stimulation (Device)
ACTIVE
Magnetic transcutaneous spinal cord stimulation
干预措施: Transcutaneous electrical nerve stimulation (Device)
PLACEBO
干预措施: Transcutaneous electrical nerve stimulation (Device)
结局指标
主要结局
Timed Up and Go - Test 5 Meters (TUG-Test 5M)
时间窗: Baseline, 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 hypotesis 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
- Timed Up and Go - Test 5 Meters (TUG-Test 5M) Dual Task(Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.)
- Percentage of freezing by video analysis of Timed Up and Go - Test(Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.)
- New Freezing of Gait Questionnaire (NFOG-Q)(Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, fourteen days after the stimulation, twenty-one days after the stimulation, twenty-eight, thirty-five and forty-two days after the stimulation.)
- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - Part III(Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.)
- Mini Balance Evaluation Systems Test (Mini-BESTest)(Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.)
- Parkinson's Disease Questionnaire 39 (PDQ-39);(Baseline, seven days after the stimulation, twenty-eight days after stimulation.)
- Falls Efficacy Scale (FES-I)(Baseline, seven days after the stimulation, twenty-eight days after stimulation.)
- Visual analog scale (VAS)(Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.)
- Freezing of gait score (FOG SCORE)(Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.)
- Activities-specific Balance Confidence (ABC) Scale(Baseline, seven days after the stimulation, twenty-eight days after stimulation.)
- Subitems 2.12 and 2.13 of Unified Parkinson's Disease Rating Scale (MDS-UPDRS)(Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, fourteen days after the stimulation, twenty-one days after the stimulation, twenty-eight, thirty-five and forty-two days after the stimulation)
- Patient Global Impression of Change (PGIC)(Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, fourteen days after the stimulation, twenty-one days after the stimulation, twenty-eight, thirty-five and forty-two days after the stimulation)
- Frontal assessment battery (FAB);(Baseline, immediately after the fifth day of stimulation, seven days after the stimulation, twenty-eight days after stimulation.)