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FES for Tremor Suppression (Tremor Trial)

N/A
Recruiting
Research Sponsored by North Carolina State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 40 years of age, and no more than 90 years of age
Have clinical evidence of rest tremor of one or both upper extremities defined as involuntary, rhythmic oscillations about any joint within the upper extremities
Must not have
Muscle weakness as determined by Medical Research Council grade less than 5/5 on direct testing in the upper limb afflicted with rest tremor
Use of medications that can alter the function of the neuromuscular junction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of study, an average of 3 years
Awards & highlights

Summary

This trial will focus on using ultrasound imaging to help detect, characterize, and differentiate tremors from voluntary hand motion in order to help design future functional electrical stimulation (FES)-based tremor-suppression techniques.

Who is the study for?
This trial is for people aged 40-90 with Parkinson's Disease or tremor conditions, who have a rest tremor in their upper extremities. The tremor must be significant and re-emergent when holding a posture. Participants should not have other neuromuscular disorders, essential tremor, be on certain medications, or have muscle weakness.Check my eligibility
What is being tested?
The study tests how well ultrasound imaging combined with electrical stimulation can identify and suppress hand tremors versus current methods like medication or surgery. It aims to differentiate between voluntary movements and involuntary tremors for better treatment strategies.See study design
What are the potential side effects?
While the description doesn't specify side effects of ultrasound imaging and electrical stimulation, common issues might include mild discomfort at the stimulation site, skin irritation from electrodes, or temporary muscle twitching during use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 40 and 90 years old.
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I experience involuntary shaking in one or both of my arms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have muscle weakness in my arm with tremors.
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I am not taking any medications that affect muscle and nerve communication.
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I currently have an infection in my arm.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of study, an average of 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of study, an average of 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Tremor Model
Tremor Suppression
Ultrasound Imaging Based Frequency Detection

Trial Design

2Treatment groups
Experimental Treatment
Group I: Tremor GroupExperimental Treatment4 Interventions
Individuals with either parkinson's disease or essential tremor will be recruited in this group
Group II: Able Body GroupExperimental Treatment4 Interventions
Individuals with no disorders will be recruited in this group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ultrasound Imaging
2018
Completed Phase 4
~750
Electromyography
2018
N/A
~240
Functional Electrical Stimulation (FES)
2017
N/A
~100

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Parkinson's Disease (PD) include dopaminergic therapies such as levodopa, dopamine agonists, MAO-B inhibitors, and amantadine. Levodopa is converted to dopamine in the brain, dopamine agonists stimulate dopamine receptors, MAO-B inhibitors prevent the breakdown of dopamine, and amantadine promotes dopamine release and has anticholinergic effects. These treatments are essential for managing motor symptoms like tremors, rigidity, and bradykinesia, thereby improving the quality of life for PD patients. Additionally, functional electrical stimulation (FES) and ultrasound imaging offer promising non-pharmacologic approaches by directly targeting and visualizing affected muscles to suppress tremors, potentially serving as adjuncts or alternatives to traditional therapies.
Neuroimaging essentials in essential tremor: a systematic review.

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillOTHER
1,526 Previous Clinical Trials
4,197,221 Total Patients Enrolled
North Carolina State UniversityLead Sponsor
34 Previous Clinical Trials
15,594 Total Patients Enrolled

Media Library

Functional Electrical Stimulation (FES) Clinical Trial Eligibility Overview. Trial Name: NCT05308368 — N/A
Parkinson's Disease Research Study Groups: Tremor Group, Able Body Group
Parkinson's Disease Clinical Trial 2023: Functional Electrical Stimulation (FES) Highlights & Side Effects. Trial Name: NCT05308368 — N/A
Functional Electrical Stimulation (FES) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05308368 — N/A
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