Using ultrasound and electrical stimulation to reduce tremors during grasping
Analysis and Suppression of Tremor During Grasp Using Ultrasound Imaging and Electrical Stimulation
This study is testing a new way to use ultrasound and electrical stimulation to help people with tremors, like those from Parkinson's disease, have better control while grasping objects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | North Carolina State University Academic / other |
| Locations | 1 site (Raleigh, North Carolina) |
| Trial ID | NCT05308368 on ClinicalTrials.gov |
What this trial studies
This study aims to address the challenges faced by individuals with tremors, particularly those with Parkinson's disease and essential tremor, by utilizing ultrasound imaging and functional electrical stimulation (FES). The approach involves detecting and characterizing tremors through advanced imaging techniques, which can provide direct visualization of the muscles involved. By combining ultrasound with FES, the study seeks to develop a closed-loop system that can effectively suppress tremors during activities like grasping. This innovative methodology aims to overcome limitations of current tremor management solutions.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 40 to 90 who have been diagnosed with Parkinson's disease and exhibit specific characteristics of tremor.
Not a fit: Patients without tremors or those whose tremors do not meet the study's specific criteria may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients by enhancing their ability to perform daily activities without the interference of tremors.
How similar studies have performed: While the use of ultrasound imaging in tremor suppression is a novel approach, previous studies have shown promise in using functional electrical stimulation for similar purposes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Raleigh, North Carolina
- Engineering Building III — Raleigh, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Nitin Sharma
- Email: nsharm23@ncsu.edu
- Phone: 919-513-0787
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.