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EIM Testing for Neuromuscular Disorders
N/A
Recruiting
Led By Tanya J Lehky, M.D.
Research Sponsored by National Institute of Neurological Disorders and Stroke (NINDS)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new, noninvasive, and painless electrical muscle testing device to see if it is helpful in evaluating muscle disorders and nerve disorders. Healthy volunteers and those with neuromuscular diseases are eligible.
Who is the study for?
This trial is for healthy individuals and those with neuromuscular diseases, aged 2 years or older. Participants must be in good health as determined by medical history, willing to follow study procedures, and able to give informed consent. Children (7-18) and adults (18+) can join; however, NIH employees involved in EMG studies cannot participate.
What is being tested?
The trial tests Electrical Impedance Myography (EIM), a technique that measures how electrical currents travel through muscles. It's compared with other standard tests like muscle ultrasonography, nerve conduction studies, and Electromyography (EMG). The goal is to evaluate its effectiveness in diagnosing various neuromuscular disorders.
What are the potential side effects?
There are minimal side effects expected from EIM testing since it's noninvasive. However, participants may feel a small shock during nerve conduction studies or discomfort when a thin needle is inserted into the muscle for EMG.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Healthy Volunteers - EIM measures for a selection of muscles with the aim of developing normative values for the NIH EMG lab
Patients - EIM measures for a selection of muscles
Secondary study objectives
Healthy Volunteers - exploratory correlations of ultrasound and electrodiagnostic methods such nerve conduction studies and less likely, EMG
Serial studies in pediatric patients
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: 1/All SubjectsExperimental Treatment4 Interventions
Healthy Volunteers and patients
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Electromyography (EMG)
2019
N/A
~260
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Who is running the clinical trial?
National Institute of Neurological Disorders and Stroke (NINDS)Lead Sponsor
1,378 Previous Clinical Trials
651,917 Total Patients Enrolled
46 Trials studying Motor Neuron Disease
21,230 Patients Enrolled for Motor Neuron Disease
Tanya J Lehky, M.D.Principal InvestigatorNational Institute of Neurological Disorders and Stroke (NINDS)
3 Previous Clinical Trials
591 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18, in good health, willing to follow the study rules, and can sign the consent form.I am a healthy child aged 7-18, can follow the study rules, and my guardian or I can sign the consent.I have a neuromuscular disorder, possibly undiagnosed, and am over 2 years old.I do not have diabetes, kidney or liver disease, history of stroke, muscle disorders, peripheral neuropathy, spine surgery, or any neuromuscular disorder.
Research Study Groups:
This trial has the following groups:- Group 1: 1/All Subjects
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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