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| ID | Type | Description | Link |
|---|---|---|---|
| 5R21EB032059 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of North Carolina, Chapel Hill | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tremor Group | Experimental | Individuals with either parkinson's disease or essential tremor will be recruited in this group |
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| Able Body Group | Experimental | Individuals with no disorders will be recruited in this group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound Imaging | Device | We will collect ultrasound images during the grasping motion for both groups |
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| Measure | Description | Time Frame |
|---|---|---|
| Tremor Model Accuracy | 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. | Through Completion of Study, an average of 3 years |
| Ultrasound Imaging Based Frequency Detection | 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. | Through Completion of Study, an average of 3 years |
| Tremor Suppression (Percentage) | 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. | Through Completion of Study, an average of 3 years |
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Inclusion Criteria (Tremor Group):
Exclusion Criteria (Tremor Group):
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Engineering Building III | Raleigh | North Carolina | 27606 | United States |
IPD will not be shared outside of this research group. However, selected data may be published in academic journals, conference papers, or other publications. This data will be de-identified, and will not include the full set of data
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2021-recruitment of 1 participant 2022- recruitment of 8 participants 2023- recruitment of 3 participants
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| ID | Title | Description |
|---|---|---|
| FG000 | Tremor Group | Individuals with either parkinson's disease or essential tremor will be recruited in this group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 20, 2023 | Aug 25, 2025 |
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The central objective of this study is to collect experimental data to develop tremor models and suppression methods and validate these methods on participants with tremor.
This study is performed with two sets of subjects: people with Parkinson's Disease and Essential Tremor and people without any neurological disorders
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| Electromyography | Device | We will collect electromyography (EMG) signals of both the flexor and extensor muscles of the wrist during the grasping motion for both groups |
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| Inertial Measurement Units (IMU) | Device | We will use data from the ultrasound images and EMG to develop a tremor model. The model will be validated in comparison to joint angle measurements from an Inertial Measurement Unit (IMU) collected during the grasping motion |
|
| Functional Electrical Stimulation (FES) | Device | We will use the develop closed-loop control methods for tremor suppression using information from the ultrasound-image based tremor models. FES will be used to provide stimulation that will help with tremor suppression |
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| COMPLETED |
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| NOT COMPLETED |
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The study's objective was to quantify the suppression effects of afferent peripheral nerve stimulation and measure tremor frequency through new sensing approaches in people with Essential Tremor or Parkinson's disease. Another objective was to model tremor dynamics through data-driven approaches. Since the able-bodied group does not exhibit tremor, they were not recruited for the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tremor Group | Individuals with either parkinson's disease or essential tremor will be recruited in this group Ultrasound Imaging: We will collect ultrasound images during the grasping motion for both groups Electromyography: We will collect electromyography (EMG) signals of both the flexor and extensor muscles of the wrist during the grasping motion for both groups Inertial Measurement Units (IMU): We will use data from the ultrasound images and EMG to develop a tremor model. The model will be validated in comparison to joint angle measurements from an Inertial Measurement Unit (IMU) collected during the grasping motion Functional Electrical Stimulation (FES): We will use the develop closed-loop control methods for tremor suppression using information from the ultrasound-image based tremor models. FES will be used to provide stimulation that will help with tremor suppression |
| BG001 | Able Body Group | Individuals with no disorders will be recruited in this group Ultrasound Imaging: We will collect ultrasound images during the grasping motion for both groups Electromyography: We will collect electromyography (EMG) signals of both the flexor and extensor muscles of the wrist during the grasping motion for both groups Inertial Measurement Units (IMU): We will use data from the ultrasound images and EMG to develop a tremor model. The model will be validated in comparison to joint angle measurements from an Inertial Measurement Unit (IMU) collected during the grasping motion Functional Electrical Stimulation (FES): We will use the develop closed-loop control methods for tremor suppression using information from the ultrasound-image based tremor models. FES will be used to provide stimulation that will help with tremor suppression |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tremor Model Accuracy | 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. | Only participants who completed assessment are included. | Posted | Mean | Standard Deviation | Normalized RMSE (%) | Through Completion of Study, an average of 3 years |
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| Primary | Ultrasound Imaging Based Frequency Detection | 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. | Only participants who completed assessment are included in the analysis | Posted | Mean | Standard Deviation | Error percentage (%) | Through Completion of Study, an average of 3 years |
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| Primary | Tremor Suppression (Percentage) | 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. | Only participants who completed these experiments are included in the analysis | Posted | Mean | Standard Deviation | Percentage Suppression | Through Completion of Study, an average of 3 years |
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3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tremor Group | Individuals with either parkinson's disease or essential tremor will be recruited in this group Ultrasound Imaging: We will collect ultrasound images during the grasping motion for both groups Electromyography: We will collect electromyography (EMG) signals of both the flexor and extensor muscles of the wrist during the grasping motion for both groups Inertial Measurement Units (IMU): We will use data from the ultrasound images and EMG to develop a tremor model. The model will be validated in comparison to joint angle measurements from an Inertial Measurement Unit (IMU) collected during the grasping motion Functional Electrical Stimulation (FES): We will use the develop closed-loop control methods for tremor suppression using information from the ultrasound-image based tremor models. FES will be used to provide stimulation that will help with tremor suppression | 0 | 12 | 0 | 12 | 0 | 12 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nitin Sharma | NC State University | 9195130787 | nsharm23@ncsu.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 1, 2024 | Oct 9, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020329 | Essential Tremor |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D004576 | Electromyography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
| D009213 | Myography |
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| >=65 years |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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