Back to results

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

Primary Purpose

Parkinson Disease, Essential Tremor

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Ultrasound Imaging

Electromyography

Inertial Measurement Units (IMU)

Functional Electrical Stimulation (FES)

About this trial

This is an interventional other trial for Parkinson Disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria (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

Exclusion Criteria (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.

Sites / Locations

Engineering Building IIIRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Tremor Group

Able Body Group

Arm Description

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

Individuals with no disorders will be recruited in this group

Outcomes

Primary Outcome Measures

Tremor Model

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 predicted angle and the true angle will be used as a metric.

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 both EMG and IMU sensors.

Tremor Suppression

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. The RMSE between the actual and desired wrist position will be used as an evaluation metric. The investigators will also analyze the FES dosage that is administered at both the flexors and extensors during the grasping motion.

Secondary Outcome Measures

Full Information

NCT ID

NCT05308368

First Posted

March 16, 2022

Last Updated

March 25, 2022

Sponsor

North Carolina State University

Collaborators

University of North Carolina, Chapel Hill

1. Study Identification

Unique Protocol Identification Number

NCT05308368

Brief Title

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

Acronym

Tremor

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 11, 2020 (Actual)

Primary Completion Date

January 1, 2100 (Anticipated)

Study Completion Date

January 1, 2100 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

North Carolina State University

Collaborators

University of North Carolina, Chapel Hill

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease, Essential Tremor

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Non-Randomized

Enrollment

16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tremor Group

Arm Type

Experimental

Arm Description

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

Arm Title

Able Body Group

Arm Type

Experimental

Arm Description

Individuals with no disorders will be recruited in this group

Intervention Type

Device

Intervention Name(s)

Ultrasound Imaging

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Electromyography

Intervention Description

We will collect electromyography (EMG) signals of both the flexor and extensor muscles of the wrist during the grasping motion for both groups

Intervention Type

Device

Intervention Name(s)

Inertial Measurement Units (IMU)

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Functional Electrical Stimulation (FES)

Intervention Description

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

Primary Outcome Measure Information:

Title

Tremor Model

Description

Time Frame

Through Completion of Study, an average of 3 years

Title

Ultrasound Imaging Based Frequency Detection

Description

Time Frame

Through Completion of Study, an average of 3 years

Title

Tremor Suppression

Description

Time Frame

Through Completion of Study, an average of 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria (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 Exclusion Criteria (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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nitin Sharma

Phone

919-513-0787

nsharm23@ncsu.edu

Facility Information:

Facility Name

Engineering Building III

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27606

Country

United States

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

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

Learn more about this trial

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

We'll reach out to this number within 24 hrs