The Effect of Subthalamic Nucleus Deep Brain Stimulation on Facial Expressions in Parkinson's Disease.
试验速览
- 阶段
- 不适用
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- The effect of Deep brain stimulation on facial expressions will be analyzed by volunteers via a web site then the results will evaluate by statistical analyses.
研究概览
简要总结
Whether Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS), a treatment commonly used to ameliorate the motor symptoms of Parkinson's disease (PD), affects on facial expressions is unclear. The purpose of this study was to investigate the potential effects of DBS and different frequencies on facial expressions of PD patients by volunteers via a web site: http://www.supporttoscience.com
详细描述
Parkinson's disease (PD) is the second most frequent progressive neuro-degenerative disease with a worldwide prevalence of 4-6 million and the mask face is an important and also troublesome sign of PD. Deep Brain Stimulation (DBS) surgery can be a viable option which has recently emerged and been accepted as a useful surgical method for PD. Standard DBS targets include Subthalamic Nucleus (STN) and Globus Pallidus Internus (GPi). Although the STN-DBS application is known to have favorable effects on motor and non-motor symptoms of PD, there is a lack information about the effect on facial expressions of PD patients. Our aim is to analyze the effect of the STN-DBS stimulation and different frequencies on the facial expressions of PD patients.
The study initially recruited 18 patients with idiopathic PD who underwent DBS surgery for movement disorders caused by PD at Mustafa Kemal University Medical Faculty Neurosurgery Department.
Inclusion criteria:
- Idiopathic PD responsive to L-Dopa treatment,
- Between 40-75 years of age,
- Having received bilateral STN DBS surgery at least six months prior to the investigation to ensure stable stimulation parameters,
- Mentally normal patients that could understand and respond to a directives. The evaluation will be made by the face photos of the patients. The face photos for the expressions including [normal], [sad], [happy], and [angry] were obtained at frequencies including 130 Hz, 60 Hz, 99 Hz, 230 Hz and off-stimulation. The face photos will evaluate by the software and by the volunteers with the aim of a website: http://www.supporttoscience.com
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Idiopathic PD responsive to L-Dopa treatment,
- •Between 40-75 years of age,
- •Having received bilateral STN DBS surgery at least one month prior to the investigation to ensure stable stimulation parameters,
- •Mentally normal patients that could understand and respond to a questionnaire.
排除标准
- •Above 75 years of age,
- •Severe dementia,
- •History of an additional neurologic disease,
- •The presence of a disease, such as the facial paralysis, that could affect facial expressions,
- •Having a wound on the face.
研究组 & 干预措施
DBS on 99 Hz.
干预措施: Deep Brain Stimulation (Device)
DBS on 130 Hz.
干预措施: Deep Brain Stimulation (Device)
DBS on 230 Hz.
干预措施: Deep Brain Stimulation (Device)
DBS off
干预措施: Deep Brain Stimulation (Device)
DBS on 60 Hz.
干预措施: Deep Brain Stimulation (Device)
结局指标
主要结局
The effect of Deep brain stimulation on facial expressions will be analyzed by volunteers via a web site then the results will evaluate by statistical analyses.
时间窗: 3 months
The evaluation of patients photos (in different frequencies and when stimulation off status) will be analyzed by volunteers via a website, then the results will be compare and evaluate by statistical analysis. The results will give us an opinion about these: The effect of Deep Brain Stimulation on Parkinsonians patients facial expression and which frequency setting is better for facial expression.
次要结局
未报告次要终点
研究者
Atilla YILMAZ
Assistant Professor
Mustafa Kemal University