Parkinson DiseaseTremorNCT05308368
Analysis and Suppression of Tremor During Grasp Using Ultrasound Imaging and Electrical Stimulation
A study testing Ultrasound Imaging, Electromyography and Inertial Measurement Units (IMU) in people with Parkinson Disease and Essential Tremor, run by North Carolina State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Essential Tremor
- What is being tested?
- Ultrasound Imaging, Electromyography and Inertial Measurement Units (IMU)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2021to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Subjects will fall under the able body category if they exhibit no movement disorders and can perform grasping motion with no inhibition.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Engineering Building III
Raleigh, North Carolina, 27606
About this study
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.
- Conditions
- Parkinson Disease, Essential Tremor
- Being tested
- Ultrasound Imaging, Electromyography, Inertial Measurement Units (IMU), Functional Electrical Stimulation (FES)
- Medical subject headings
- Parkinson Disease, Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound ImagingDevice
We will collect ultrasound images during the grasping motion for both groups
ElectromyographyDevice
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)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
| Study group | Role | What they receive |
|---|---|---|
| Tremor Group | Experimental | Individuals with either parkinson's disease or essential tremor will be recruited in this group Receives: Device: Ultrasound Imaging; Device: Electromyography; Device: Inertial Measurement Units (IMU); Device: Functional Electrical Stimulation (FES) |
| Able Body Group | Experimental | Individuals with no disorders will be recruited in this group Receives: Device: Ultrasound Imaging; Device: Electromyography; Device: Inertial Measurement Units (IMU); Device: Functional Electrical Stimulation (FES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Through Completion of Study, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start11 Apr 2021
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Carolina State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Responsible party
- Principal investigator, Nitin Sharma, North Carolina State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308368
- Sponsor's protocol ID
- 19247
- Other IDs
- 5R21EB032059
- Acronym
- Tremor
- Status last verified
- Oct 2025
- First submitted
- 16 Mar 2022
- Last updated
- 27 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis and Suppression of Tremor During Grasp Using Ultrasound Imaging and Electrical Stimulation
- ClinicalTrials.gov ID
- NCT05308368
- Acronym / sponsor ID
- Tremor / 19247
- Conditions
- Parkinson Disease, Essential Tremor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- North Carolina State UniversityUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Study start
- 11 Apr 2021 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 4 Apr 2022 (actual)
- Results
- Posted 27 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Tremor Group | Experimental | Device: Ultrasound Imaging, Device: Electromyography, Device: Inertial Measurement Units (IMU), Device: Functional Electrical Stimulation (FES)Individuals with either parkinson's disease or essential tremor will be recruited in this group |
| Able Body Group | Experimental | Device: Ultrasound Imaging, Device: Electromyography, Device: Inertial Measurement Units (IMU), Device: Functional Electrical Stimulation (FES)Individuals with no disorders will be recruited in this group |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound ImagingWe will collect ultrasound images during the grasping motion for both groups | Device | Able Body Group, Tremor Group |
| ElectromyographyWe will collect electromyography (EMG) signals of both the flexor and extensor muscles of the wrist during the grasping motion for both groups | Device | Able Body Group, Tremor Group |
| 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 | Device | Able Body Group, Tremor Group |
| 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 | Device | Able Body Group, Tremor Group |
Primary outcome
Tremor Model Accuracy
Time frame: 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
Time frame: 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)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Imaging, Electromyography and Inertial Measurement Units (IMU) in people with Parkinson Disease and Essential Tremor, run by North Carolina State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tremor Model Accuracy (time frame: Through Completion of Study, an average of 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025.