Battery-preserving Stimulation Patterns to Improve Symptoms in Parkinson's Disease and Essential Tremor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Evaluate the efficacy of novel stimulation patterns by the Tremor Rating Scale
研究概览
简要总结
The purpose of this research study is to test effectiveness of different deep brain stimulation (DBS) stimulation patterns on symptoms that may also improve the life of the battery. If these patterns are effective, the implanted batteries will be drained more slowly and last longer than currently expected. An increase in battery life may reduce the number of surgeries needed to replace them.
详细描述
Deep brain stimulation (DBS) is an effective surgical therapy for medication-refractory symptoms of Parkinson's disease, tremor, and dystonia. Patients implanted with DBS experience a significant improvement of their symptoms with relatively low risk of intolerable side effects. Implanted patients must undergo repeat surgeries to replace the Implantable Pulse Generators/batteries (IPG) approximately every 2 to 5 years. The DBS program (at the University of Florida) has studied battery consumption and has been interested in potential strategies to extend the life of the IPG to reduce the need for frequent battery replacement surgeries, while improving symptom-relief, patient satisfaction, and the potential associated financial burdens.
The research study will evaluate the effects of novel stimulation patterns on tremor, bradykinesia, rigidity and gait in Parkinson's disease and essential tremor patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of Parkinson's disease or Essential Tremor by strict criteria
- •Deep brain stimulation (DBS) already implanted
- •Optimized Deep brain stimulation (DBS) settings (or at least 4 months of DBS programming)
排除标准
- •Other neurological diagnoses (co-existent Alzheimer's or ALS)
- •No Deep brain stimulation (DBS)
- •less than 4 Deep brain stimulation (DBS) programming
结局指标
主要结局
Evaluate the efficacy of novel stimulation patterns by the Tremor Rating Scale
时间窗: Baseline to Day 1
Tremor Rating Scale (TRS), consists of 11 items that evaluate tremor in the head, arms, and legs. The rater assigns a score of 0 to 4 for each item, in ascending order of severity. The subjet will be videotaped and two raters blinded to conditions will score the TRS.
Kinesia accelerometer to measure motor dysfunction
时间窗: Baseline to Day 1
The Kinesia system includes a unit worn by the subject and software that is used to collect, manage, and analyze data. The system measures three-dimensional motion using three orthogonal accelerometers and three orthogonal gyroscopes located in the sensor module.The digital data is received by the Receiver connected to a computer and processed by the Kinesia software package.
Evaluate the efficacy of novel stimulation patterns by the Unified Parkinson's Disease Rating Scale
时间窗: Baseline to Day 1
The Unified Parkinson's Disease Rating Scale (UPDRS) is used by neurologists to rate the motor impairment of people with Parkinson's Disease. The rater obtains the score by observation and questioning the participant. Higher scores represent greater impairment and scores range from 0-108. The subject will be videotaped and two raters blinded to conditions will score the UPDRS.
Trigno wireless system to measure motor dysfunction
时间窗: Baseline to Day 1
This system has sensors with a multi-function design and therefore along with recording of surface EMG signal, it allows Triaxial Accelerometry. This wireless EMG machine will measure muscle contractions.
GaitRite walking assessment.
时间窗: Baseline to Day 1
The GaitRite is an automated floor that when the subjects walk on the floor it records the gait pattern.
次要结局
- Battery Consumption compared between pre and post settings(Baseline to Day 1)