What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease (PD) include medications like levodopa, dopamine agonists, and cholinesterase inhibitors, as well as surgical options like deep brain stimulation (DBS). Levodopa can cause motor fluctuations and dyskinesias over time. Dopamine agonists may lead to side effects such as nausea, dizziness, hallucinations, and impulse control disorders. Cholinesterase inhibitors, used for cognitive symptoms, can worsen tremors and cause nausea and vomiting. DBS, while effective for tremor control, carries risks of surgical complications, including infection, bleeding, and hardware-related issues. Non-pharmacological treatments like FES and ultrasound imaging-based techniques are being explored to minimize these side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Parkinson's Disease, focusing primarily on pharmacologic options and non-invasive methods to manage symptoms, including tremors. Key pharmacologic treatments include nonergot dopamine agonists like pramipexole, ropinirole, and transdermal rotigotine, which help reduce motor symptoms by stimulating dopamine receptors. Additionally, MAO-B inhibitors such as selegiline and rasagiline are used to prolong the effect of dopamine in the brain. For non-pharmacologic approaches, deep brain stimulation (DBS) has been approved to manage severe tremors and motor fluctuations. While functional electrical stimulation (FES) combined with technologies like ultrasound imaging is still under investigation, these existing treatments provide a foundation for managing Parkinson's Disease symptoms.

What other types of research exist?

Promising novel alternatives to ultrasound imaging for detecting and characterizing tremors in Parkinson's Disease patients include: 1) Wearable motion sensors (accelerometers and gyroscopes) that provide real-time data on tremor frequency and amplitude. 2) Electromyography (EMG) sensors that measure muscle activity and can differentiate between voluntary and involuntary movements. 3) Advanced MRI techniques, such as functional MRI (fMRI), which can visualize brain activity related to tremor generation. These technologies can be integrated into a closed-loop system for more effective FES-based tremor suppression.

← Back to Search

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

No Placebo-Only Group

Summary

This trial uses ultrasound imaging to study and understand hand tremors. It aims to help people with tremor disorders by accurately identifying involuntary muscle movements. The study includes both people with tremors and those without.

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.

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.

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

Select...

I am between 40 and 90 years old.

Select...

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:

Select...

I have muscle weakness in my arm with tremors.

Select...

I am not taking any medications that affect muscle and nerve communication.

Select...

I currently have an infection in my arm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through completion of study, an average of 3 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Tremor Model

Tremor Suppression

Ultrasound Imaging Based Frequency Detection

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~760

Functional Electrical Stimulation (FES)

2017

N/A

~100

Electromyography

2018

N/A

~320

0 / 5Eligibility criteria met

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.