Analysis and Suppression of Tremor During Grasp Using Ultrasound Imaging and Electrical Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Ultrasound Imaging Based Frequency Detection
研究概览
简要总结
Individuals experiencing tremors face difficulty performing activities of daily living caused by involuntary oscillation of the muscles in the hands and arms. Current solutions to help suppress tremors include medication, surgery, assistive devices and lifestyle change. However, each of these has a drawback of its own including cost and unwanted side effects. Aside from the solutions listed, it has been shown that functional electrical stimulation (FES) is a possible solution to help suppress tremor. Additionally, FES can be combined with different technologies including accelerometers, gyroscopes and motion capture to develop a closed loop system for tremor suppression. However, this has drawbacks including signal interference and the need for multiple sensor to fully classify the tremor. Ultrasound imaging solves some of these issues because it can provide a direct visualization of hand muscles that contribute to tremor. This study will focus on detecting characterizing and differentiating tremors from voluntary hand motion using ultrasound imaging. The results obtained from this study will help design FES-based tremor-suppression techniques in the future. This study will target both subjects with different tremor disorders and able bodied subjects.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(Tremor Group):
- •At least 40 years of age, and no more than 90 years of age.
- •Meet UK Parkinson's disease brain bank diagnostic criteria
- •Have clinical evidence of rest tremor of one or both upper extremities defined as involuntary, rhythmic oscillations about any joint within the upper extremities
- •Tremor amplitude must be at minimum 1 cm as determined by expert opinion by a movement disorders specialist.
- •Due to the nature of measurements occurring during a grasp maneuver, the tremor must be deemed to become re-emergent with a fixed posture. This shall be defined by development of postural tremor that does not begin immediately upon grasping the vertical object, but instead with a delay in development of oscillatory movement of at least half a second as timed by a stopwatch, and that may grow in amplitude over seconds to maximum amplitude without changing the force of the grasp at first. Note that within-individual intermittency and variability of tremor can be influenced by anxiety, stress, cold temperature, and fatigue. In an effort to reduce this variability, we will have subjects perform tasks in a comfortable area, providing up to 20 minutes to allow them to relax in a temperature-neutral location, and reduce anxiety
排除标准
- •(Tremor Group):
- •Muscle weakness as determined by Medical Research Council grade less than 5/5 on direct testing in the upper limb afflicted with rest tremor
- •Infection at the upper limb at time of assessment
- •Pre-existing, concomitant neuromuscular or cerebellar disorders
- •Use of medications that can alter the function of the neuromuscular junction.
- •Those with concomitant essential tremor as determined by history or confirmed by movement disorders specialist prior to assessments.
- •Inclusion Criteria (Able Body):
- •Subjects will fall under the able body category if they exhibit no movement disorders and can perform grasping motion with no inhibition.
研究组 & 干预措施
Tremor Group
Individuals with either parkinson's disease or essential tremor will be recruited in this group
干预措施: Ultrasound Imaging (Device)
Tremor Group
Individuals with either parkinson's disease or essential tremor will be recruited in this group
干预措施: Electromyography (Device)
Tremor Group
Individuals with either parkinson's disease or essential tremor will be recruited in this group
干预措施: Inertial Measurement Units (IMU) (Device)
Tremor Group
Individuals with either parkinson's disease or essential tremor will be recruited in this group
干预措施: Functional Electrical Stimulation (FES) (Device)
Able Body Group
Individuals with no disorders will be recruited in this group
干预措施: Ultrasound Imaging (Device)
Able Body Group
Individuals with no disorders will be recruited in this group
干预措施: Electromyography (Device)
Able Body Group
Individuals with no disorders will be recruited in this group
干预措施: Inertial Measurement Units (IMU) (Device)
Able Body Group
Individuals with no disorders will be recruited in this group
干预措施: Functional Electrical Stimulation (FES) (Device)
结局指标
主要结局
Ultrasound Imaging Based Frequency Detection
时间窗: Through Completion of Study, an average of 3 years
The investigators will benchmark the performance of the ultrasound features (fascicle length \[mm\], muscle thickness \[mm\]) in detecting the actual tremor frequency (Hz) measured by an inertial measurement unit (IMU) sensor and electromyography (EMG). Here error between the tremor frequency measured with IMU and the ultrasound feature-derived tremor frequency is reported. A lower mean error (0-100%) implies higher concurrence with the IMU-derived or EMG-derived tremor frequency.
Tremor Model Accuracy
时间窗: Through Completion of Study, an average of 3 years
The investigators will use ultrasound features collected on participants to develop novel models for tremor that can accurately predict the joint position. The joint position measured by the IMU will used as a benchmark and the root mean squared error (RMSE \[Deg.\]) between the model's predicted joint angle and the true angle will be used as a metric. A higher RMSE (in the scale of 0-100%) implies lower model accuracy.
Ultrasound Imaging Based Frequency Detection
时间窗: Through Completion of Study, an average of 3 years
The investigators will benchmark the performance of the ultrasound features (fascicle length \[mm\], muscle thickness \[mm\]) in detecting the actual tremor frequency (Hz) measured by an inertial measurement unit (IMU) sensor and electromyography (EMG). Here error between the tremor frequency measured with IMU and the ultrasound feature-derived tremor frequency is reported. A lower mean error (0-100%) implies higher concurrence with the IMU-derived or EMG-derived tremor frequency.
Tremor Suppression (Percentage)
时间窗: Through Completion of Study, an average of 3 years
The investigators will use the developed tremor models to develop closed loop control methods using FES which enable tremor suppression. The goal of the controller will be to maintain a desired wrist angle position while performing a grasping motion. A tremor suppression ratio metric, formulated as 1-(W\_t/W\_b), where W\_t is the angular velocity of the wrist around the vertical during periods in which stimulation was turned on and W\_b is the angular velocity during baseline periods without any stimulation, is used as an evaluation metric. A higher tremor suppression ratio (0-100%) means higher effectiveness in suppressing the tremor.
次要结局
未报告次要终点
研究者
Nitin Sharma
Associate Professor
North Carolina State University