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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

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Healthy Volunteers - exploratory correlations of ultrasound and electrodiagnostic methods such nerve conduction studies and less likely, EMG

Serial studies in pediatric patients

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)Lead Sponsor

1,340 Previous Clinical Trials

649,084 Total Patients Enrolled

Tanya J Lehky, M.D.Principal InvestigatorNational Institute of Neurological Disorders and Stroke (NINDS)

3 Previous Clinical Trials

591 Total Patients Enrolled

Media Library

Electrical Impedance Myography Clinical Trial Eligibility Overview. Trial Name: NCT01900132 — N/A

Neuromuscular Disease Research Study Groups: 1/All Subjects

Neuromuscular Disease Clinical Trial 2023: Electrical Impedance Myography Highlights & Side Effects. Trial Name: NCT01900132 — N/A

Electrical Impedance Myography 2023 Treatment Timeline for Medical Study. Trial Name: NCT01900132 — N/A

Frequently Asked Questions

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

Is registration open for this experiment?

"Affirmative. Records on clinicaltrials.gov demonstrate that this clinical trial is currently open for enrollment and was initially posted online on June 20th 2013. The study requires 275 participants to be gathered from two sites, with its most recent update occurring October 12th 2022."

Answered by AI

What is the underlying purpose of this research endeavor?

"This medical trial aims to establish normative values for the NIH EMG lab via Healthy Volunteer End-of-Study EIM assessments as its primary outcome. Secondary objectives include exploratory correlations of ultrasound and electrodiagnostic methods such nerve conduction studies, serial measures of EIM in paediatric patients with neuromuscular disorders, and less likely EMG evaluations using an EIM device."

Answered by AI

What is the aggregate figure of participants in this trial?

"Yes, clinicaltrials.gov verifies that this research endeavour is actively recruiting participants. It was initially posted on June 20th 2013 and last updated on October 12th 2022; it requires 275 recruits from 2 different locations."

Answered by AI

Recent research and studies

Muscle & NerveJournal

Electrical Impedance Myography Discriminates Congenital Muscular Dystrophy from Controls

Schwartz, Daniel P., Jahannaz Dastgir, Anam Salman, Barbara Lear, Carsten G. Bönnemann, and Tanya J. Lehky. 2015. “Electrical Impedance Myography Discriminates Congenital Muscular Dystrophy from Controls”. Muscle & Nerve. Wiley. doi:10.1002/mus.24770.

Muscle & NerveJournal

Electrical Impedance Myography in Individuals with Collagen 6 and Laminin Α‐2 Congenital Muscular Dystrophy: A Cross‐sectional and 2‐year Analysis

Nichols, Carmel, Minal S. Jain, Katherine G. Meilleur, Tianxia Wu, James Collins, Melissa R. Waite, Jahannaz Dastgir, et al.. 2017. “Electrical Impedance Myography in Individuals with Collagen 6 and Laminin Α‐2 Congenital Muscular Dystrophy: A Cross‐sectional and 2‐year Analysis”. Muscle & Nerve. Wiley. doi:10.1002/mus.25629.

c9orf72Journal

Electrical Impedance Myography (EIM) in a Natural History Study of <i>c9orf72</i> Mutation Carriers

Offit, Michelle B., Tianxia Wu, Mary Kay Floeter, and Tanya J. Lehky. 2020. “Electrical Impedance Myography (EIM) in a Natural History Study of c9orf72 Mutation Carriers”. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration. Informa UK Limited. doi:10.1080/21678421.2020.1752247.

clinicaltrials.govStudy