Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 90 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

(Tremor Group): 1. At least 40 years of age, and no more than 90 years of age. 2. Meet UK Parkinson's disease brain bank diagnostic criteria 3. Have clinical evidence of rest tremor of one or both upper extremities defined as involuntary, rhythmic oscillations about any joint within the upper extremities 4. Tremor amplitude must be at minimum 1 cm as determined by expert opinion by a movement disorders specialist. 5. 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

Exclusion Criteria

(Tremor Group): 1. Muscle weakness as determined by Medical Research Council grade less than 5/5 on direct testing in the upper limb afflicted with rest tremor 2. Infection at the upper limb at time of assessment 3. Pre-existing, concomitant neuromuscular or cerebellar disorders 4. Use of medications that can alter the function of the neuromuscular junction. 5. 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Intervention 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
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Tremor Group
Individuals with either parkinson's disease or essential tremor will be recruited in this group
  • Device: Ultrasound Imaging
    We will collect ultrasound images during the grasping motion for both groups
  • Device: Electromyography
    We will collect electromyography (EMG) signals of both the flexor and extensor muscles of the wrist during the grasping motion for both groups
  • Device: 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: 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
Experimental
Able Body Group
Individuals with no disorders will be recruited in this group
  • Device: Ultrasound Imaging
    We will collect ultrasound images during the grasping motion for both groups
  • Device: Electromyography
    We will collect electromyography (EMG) signals of both the flexor and extensor muscles of the wrist during the grasping motion for both groups
  • Device: 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: 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

Recruiting Locations

More Details

NCT ID
NCT05308368
Status
Completed
Sponsor
North Carolina State University

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.