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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of study, an average of 3 years
Awards & highlights

Tremor Trial 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.

Tremor Trial 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.

Tremor Trial 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

Tremor 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
~730
Electromyography
2018
N/A
~210
Functional Electrical Stimulation (FES)
2017
N/A
~100

Find a Location

Who is running the clinical trial?

North Carolina State UniversityLead Sponsor
33 Previous Clinical Trials
15,544 Total Patients Enrolled
University of North Carolina, Chapel HillOTHER
1,500 Previous Clinical Trials
4,186,702 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many candidates is this trial accepting for enrollment?

"Affirmative. According to clinicaltrials.gov, the trial is actively searching for 16 volunteers from a single location; it was initially posted on February 11th 2020 and last updated on March 25th 2022."

Answered by AI

Are there still opportunities for participation in this trial?

"According to current information on clinicaltrials.gov, this trial is actively seeking participants. This research was first announced on February 11th 2020 and the most recent update came out on March 25th 2022."

Answered by AI

Are there any qualifications that would make an individual ineligible to participate in this experiment?

"This medical study is seeking 16 individuals between the ages of 18 and 90 who are afflicted with familial tremor. All participants must be at least 40 years old, meet certain UK Parkinson's brain bank criteria, have evidence of rest tremors in one or both upper extremities, demonstrate postural tremor which does not begin immediately upon grasping a vertical object but instead has an onset delay of half a second as measured by stopwatch, exhibit a minimum amplitude of 1 cm according to expert opinion from a movement disorder specialist, and complete tasks in comfortable conditions where they can relax for up to 20 minutes in order to reduce any variability due stress factors such"

Answered by AI

Is this research open to individuals aged over 30?

"As outlined in the study's requirements, participants must be between 18 to 90 years of age."

Answered by AI
~11 spots leftby Jan 2100