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

Not Applicable

Recruiting

• Conditions: Essential Tremor; Parkinson Disease
• Interventions: Device: Ultrasound Imaging; Device: Electromyography; Device: Inertial Measurement Units (IMU); Device: Functional Electrical Stimulation (FES)

• Registration Number: NCT05308368
• Lead Sponsor: North Carolina State University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-11
• Status Verified: 2022-03
• Study First Submitted: 2022-03-16
• Study First Submitted QC: 2022-03-25
• Last Update Submitted: 2022-03-25
• Study First Posted: 2022-04-04
• Last Update Posted: 2022-04-04
• Primary Completion: 2100-01-01
• Study Completion: 2100-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Able Body Group	Inertial Measurement Units (IMU)	Individuals with no disorders will be recruited in this group
Tremor Group	Ultrasound Imaging	Individuals with either parkinson's disease or essential tremor will be recruited in this group
Tremor Group	Electromyography	Individuals with either parkinson's disease or essential tremor will be recruited in this group
Able Body Group	Ultrasound Imaging	Individuals with no disorders will be recruited in this group
Able Body Group	Electromyography	Individuals with no disorders will be recruited in this group
Able Body Group	Functional Electrical Stimulation (FES)	Individuals with no disorders will be recruited in this group
Tremor Group	Inertial Measurement Units (IMU)	Individuals with either parkinson's disease or essential tremor will be recruited in this group
Tremor Group	Functional Electrical Stimulation (FES)	Individuals with either parkinson's disease or essential tremor will be recruited in this group

Primary Outcome Measures

Name	Time	Method
Ultrasound Imaging Based Frequency Detection	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 both EMG and IMU sensors.
Tremor Model	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 predicted angle and the true angle will be used as a metric.
Tremor Suppression	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. 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.

Trial Locations

Locations (1)

Engineering Building III; 🇺🇸 Raleigh, North Carolina, United States