Evaluation of the Influence of Deep Brain Stimulation on the Spinal Deformities Associated With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Sagittal Imbalance
研究概览
简要总结
The intention of the study is to investigate whether Deep Brain Stimulation (DBS) will improve postural deformities of patients with Parkinson's disease.
详细描述
- Introduction
Postural deformities are frequent comorbidities that limit the quality of life in patients with Parkinson's disease. Subject of the study is the investigation of postural deformities as a concomitant disease in connection with therapy with DBS. The aim of this prospective study is to examine the effect of deep brain stimulation on postural instability and thus the quality of life of patients. 2. Study outline
The aim of this prospective study is to investigate the effect of DBS on postural instability and thus the quality of life of patients.
For this purpose, the investigators would like to evaluate 50 participants before and at certain time points (three, six, twelve and 24 months) after DBS surgery. X-rays of the entire spine are carried out using EOS® technology and biodynamic measurements of the spine using the Epionics SPINE ® system. In addition, the Investigators collect the 39-item PD Questionnaires (PDQ-39), Unified Parkinson's Disease Rating Scale (UPDRS) Part III, Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) as clinical parameters.
Our hypotheses (I): DBS improves the sagittal balance of the spine and the pelvic rotation as a corresponding compensation mechanism for this incorrect posture (II) The participant's mobility improves in course of DBS in terms of scope and speed (III) In course after DBS, back pain is significantly reduced and the participant's everyday life is easier to cope with.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The Radiologist who evaluated X-rays ist masked regarding timepoint of investigation
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •women and men, over 18 years of age
- •medical indication for deep brain Stimulation for Parkinson's Disease
- •signed declaration of consent
排除标准
- •withdrawal of consent
- •non-Parkinson's-associated diseases of the spine
- •pregnancy
结局指标
主要结局
Sagittal Imbalance
时间窗: Two years after DBS
Sagittal vertical axis (SVA) in X-Ray of the Spine. SVA is identified as the location of the head with respect to the normal center of gravity by a plumb line dropped from the center of the C7 vertebral body to the posterior superior corner of the sacral end plate. It is measured in cm with pathological values \>5cm and sagital Imbalance defined as SVA \>10cm.
次要结局
- Pelvic incidence (PI)(Two years after DBS)
- Spine Mobility(Two years after DBS)
- Unified Parkinsons Disease Rating Scala (Part III Motor Examination) (UPDRS-Part III)(Two years after DBS)
- Visual Analoge Scale (VAS)(Two years after DBS)
- Sacral slope (SS)(Two years after DBS)
- Oswestry Disability Index (ODI)(Two years after DBS)
- Scoliosis(Two years after DBS)
- Parkinsons Disease Questionaire 39 (PDQ-39)(Two years after DBS)
- Pelvit tilt (PT)(Two years after DBS)
- Lumbar Lordisis (LL)(Two years after DBS)
- Mismatch of Pelvic incidence and LL (PI - LL)(Two years after DBS)
研究者
Philipp Spindler
Dr. med. Philipp Spindler, Resident, Principal Investigator, Charite University medicine / department of neurosurgery
Charite University, Berlin, Germany