Analysis and Suppression of Tremor During Grasp Using Ultrasound Imaging and Electrical Stimulation

NCT05308368 | Completed Results

• 2 other identifiers: 192475R21EB032059
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Tremor Group

EXPERIMENTAL

Individuals with either parkinson's disease or essential tremor will be recruited in this group

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

Device: Ultrasound Imaging; Device: Electromyography; Device: Inertial Measurement Units (IMU); Device: Functional Electrical Stimulation (FES)

Interventions

Ultrasound Imaging DEVICE

We will collect ultrasound images during the grasping motion for both groups

Able Body Group; Tremor Group

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

Able Body Group; Tremor Group

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

Able Body Group; Tremor Group

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

Able Body Group; Tremor Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Subjects will fall under the able body category if they exhibit no movement disorders and can perform grasping motion with no inhibition.

Sponsors & Collaborators

• North Carolina State University: lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

Engineering Building III

Raleigh, North Carolina, 27606, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Essential Tremor

Interventions

Ultrasonography; Electromyography

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Myography

Results Point of Contact

• Title: Nitin Sharma
• Organization: NC State University

nsharm23@ncsu.edu

9195130787

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: April 4, 2022
• Study Start: April 11, 2021
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: October 27, 2025
• Results First Posted: October 27, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)