Sacral Nerve Stimulation in the Treatment of Gait Disorder in Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Parameter changes in Timed Up and Go Test
研究概览
简要总结
Parkinson's disease (PD) is a progressive disease, characterized by dopaminergic neurons degeneration in the substantia nigra. Postural and gait disorders usually occur in advanced PD patients. However, existing drugs and deep brain stimulation (DBS) therapy are not effective enough for these axial symptoms or cannot maintain long-term efficacy, which seriously reduce patients' quality of life. Sacral nerve stimulation(SNS) is a treatment for urinary symptoms in PD. It has been reported that SNS can also improve PD gait disturbance, but the level of evidence currently is low. We assume that SNS may have a similar mechanism to spinal cord stimulation and may be an effective treatment for PD gait disorder. However, there are few studies on the mechanism of SNS treatment. Therefore, we will conduct a large sample, prospective case-control study to provide a higher level of clinical evidence for sacral nerve stimulation in the treatment of gait disturbance in PD. Our primary objective is to evaluate the efficacy of SNS for gait disorder in PD. PD patients who have received DBS surgery but still have severe gait problems will be included. This study will contribute to evaluate the efficacy of SNS for gait disorder in PD, provide level II evidence for expanding the indications of SNS, varicocelectomy., and improve patients' quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic Parkinson's disease, Hoehn & Yahr stage (medication off condition) at 2~4;
- •Gait and balance disorder, unstable posture, frequently falls (gaze and fall questionnaire (GFQ) score > 32) and severe dysuria, extremely affects quality of life (overactive bladder score (OABSS) ≥12);
- •SCS eligibility has been confirmed by neurologist and neurosurgeon;
- •Patients willingly seek surgical treatment for PD gait disturbance；
- •Ability to perform a gait/walking task (under close supervision);
- •Informed consent and have good compliance.
排除标准
- •Lesion in spinal nerve or other surgical contraindications;
- •Severe depression (Beck Depression Inventory scores > 25) or dementia (Mini Mental State Examination < 24);
- •Medical history of stroke, amyotrophic lateral sclerosis or myasthenia gravis;
- •Other neuropsychiatric disorders or relevant medical history;
- •Taking prohibited medications (such as lithium, valproate, steroids, adrenergic agonists, etc.);
- •Cardiac, renal or other important organs hypofunction or dysfunction, or unstable vital signs;
- •Women reporting that they are pregnant;
- •Any situation (medical, psychological, social, geographical, etc.) that may endanger patient's life or result in patients withdrawing from the study at present or in the future.
研究组 & 干预措施
Sacral Nerve Stimulation
Intervention: Sacral nerve Stimulation Stimulation sites：S3 Postoperative study visits lasted approximately 3 hours and were conducted in 3 months.
干预措施: Sacral Nerve Stimulation (Device)
No SNS Intervention
结局指标
主要结局
Parameter changes in Timed Up and Go Test
时间窗: Baseline (preoperative), during external test stimulation (1-14 days after electrode implantation), 3 months post-SNS
Patients should stand up from the chair, walk forward for 3m with daily speed, turn after passing the marked line, and then walk back to the chair and sit down, leaning back in the chair. Video recordings will be made throughout the test.
次要结局
- Changes in Berg Balance scale (BBS) scores(Baseline (preoperative), 3 months post-SNS)
- Changes in 8-item Parkinson's Disease Questionnaire (PDQ-8) scores(Baseline (preoperative), 3 months post-SNS)
- Changes in Montreal cognitive assessment (MoCA) scores(Baseline (preoperative), 3 months post-SNS)
- Changes in Unified Parkinson's Disease Rating Scale Part Ⅲ (UPDRS Ⅲ) scores(Baseline (preoperative), 3 months post-SNS)
- Changes in Gait and Fall Questionnaire (GFQ) scores(Baseline (preoperative), 3 months post-SNS)
- Parameter changes in Dual task(Baseline (preoperative), 3 months post-SNS)
- Parameter changes in Six-Minute Walking Test(Baseline (preoperative), 3 months post-SNS)
- Parameter changes in Rapid 360° Turn(Baseline (preoperative), 3 months post-SNS)
- Changes in EuroQol-5 Dimensions (EQ-5D) scores(Baseline (preoperative), 3 months post-SNS)
- Changes in Voiding Diary(Baseline (preoperative), during external test stimulation (1-14 days after electrode implantation), 3 months post-SNS)
研究者
Bomin Sun
Bomin Sun, Chief physician, Ruijin Hospital
Ruijin Hospital