Clinical trial NCT05308368: Analysis and Suppression of Tremor During Grasp Using Ultrasound Imaging and Electrical Stimulation
Official title: Analysis and Suppression of Tremor During Grasp Using Ultrasound Imaging and Electrical Stimulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Essential Tremor
Lead sponsor: North Carolina State University
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
First posted: 2022-04-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Tremor Model
timeFrame: Through Completion of Study, an average of 3 years
measure: Ultrasound Imaging Based Frequency Detection
timeFrame: Through Completion of Study, an average of 3 years
measure: Tremor Suppression
timeFrame: Through Completion of Study, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: Engineering Building III
state: North Carolina
Study officials:
References: