Trial record 3 of 69 for:    Hereditary Neuropathies

Electrical Impedance Myography: Exploratory Studies in Healthy People and People With Neuromuscular Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier:
NCT01900132
First received: July 11, 2013
Last updated: June 6, 2014
Last verified: April 2014
  Purpose

Background:

- Electrical impedance myography (EIM) is a new technique being studied to see if it is helpful in evaluating muscle disorders and nerve disorders. EIM looks at how a mild, painless electrical current travels through muscles. Researchers want to gain experience in using the EIM device. They will collect information on the results of using it on people with and without nerve and muscle diseases, and compare that with information from other standard tests. First, they will test the device on healthy people. Then they will test people with a variety of neuromuscular diseases. Because the test is noninvasive and not painful, researchers will test both children and adults.

Objectives:

- To gain experience using the EIM muscle testing device.

Eligibility:

  • Healthy volunteers at least 2 years old.
  • Individuals at least 2 years old who have neuromuscular disease.

Design:

  • Participants will be screened with a medical history and physical exam.
  • Participants will have one 2 3 hour clinic visit. Researchers may request follow-up visits.
  • Participants will be tested with the EIM device. The device and small electrodes will be placed on their skin. An electric current will pass through the device, but the participants will not feel this.
  • Participants may have an ultrasound test. A gel will be put on their skin, and a device will be moved over the skin.
  • Participants may have a nerve test. Electrodes will be placed on their skin, and they will feel a small shock.
  • Participants may have a test where a thin needle is inserted in their muscle.

Condition
Neuromuscular Disease
Motor Neuron Disease
Inherited Neuromuscular Conditions
Inherited Neuropathies

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Electrical Impedance Myography: Exploratory Studies in Normal Subjects and Patients With Neuromuscular Disorders

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Normative values for EIM in healthy volunteers. In subjects with neuromuscular disorders, we would be mainly doing explorational studies to better understand the use of EIM in disease. [ Time Frame: Cross-sectional study ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: June 2013
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Detailed Description:

Objective: This is an observational exploratory protocol for the use of electrical impedance myography (EIM) device in the study of neuromuscular disorders. The aim is to gain proficiency in the use of EIM device initially with healthy volunteers and try to correlate its use with other modalities such as muscle ultrasound and electrodiagnostic techniques. We will extend this into the investigation of subjects with a variety of neuromuscular disease.

Study: 125 healthy volunteers and 125 subjects with neuromuscular disease. The subjects will be adults and children, healthy volunteers and subjects with neuromuscular disease. Initially, we will evaluate the EIM in healthy volunteers. Since the advantage of the EIM is that it is noninvasive and nonpainful, we will be evaluating pediatric population.

Design: The studies will be performed in the outpatient clinic. For the healthy volunteers we will be evaluating EIM along with possible ultrasound and electrodiagnostic methods. A single session will be 3hours or less. Repeat studies may be performed to establish reproducibility after the initial studies are completed. For subjects with neuromuscular disease, the studies will be conducted in a single outpatient session of 3 hours or less, unless a follow-up study is requested by the primary team. For children, the session will be 2 hours or less.

Outcome measures: This is an exploratory protocol for the use of the EIM device. We aim to develop lab normative values for EIM using healthy volunteers. For subjects with neuromuscular disease we aim to understand the value of EIM as a type of biomarker for different neuromuscular disorders. Eventually, we would like to incorporate EIM into clinical trials as a biomarker though this is not within the scope of the current protocol. As a secondary outcome measures, we will explore correlations between EIM and ultrasound and other electrodiagnostic methods.

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • HEALTHY VOLUNTEERS-ADULTS

INCLUSION CRITERIA:

Healthy adults, aged 18- or older, willing to participate

EXCLUSION CRITERIA:

  1. Medical conditions that require medications that affect the physiological measures being tested. Some conditions that may be excluded are diabetes, kidney and liver disease.
  2. History of stroke, muscle disorders, peripheral neuropathy or spine surgery
  3. Subjects who are unable to provide informed consent

HEALTHY VOLUNTEERS-PEDIATRIC

INCLUSION CRITERIA:

Healthy children, age 7-18, willing to participate

EXCLUSION CRITERIA:

  1. Medical conditions that require medications that affect the physiological measures being tested. Some conditions that may be excluded are diabetes, kidney and liver disease.
  2. History of stroke, muscle disorders, peripheral neuropathy or spine surgery
  3. Subjects who are unable to provide informed consent or assent

SUBJECTS WITH NEUROMUSCULAR DISEASE

INCLUSION CRITERIA:

  1. Suspected motor neuron disease or
  2. Suspected myopathy or
  3. Suspected neuropathy or
  4. Suspected movement disorders that impair intracortical processes
  5. Age of 2 years or older
  6. Subjects who are unable to provide consent may be included if they have the appropriate Durable Power of Attorney (DPA).

EXCLUSION CRITERIA:

You may not be eligible for this study if we are unable to obtain informed consent.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01900132

Contacts
Contact: Ronald F Kuster (301) 496-5295 rkuster@mail.nih.gov
Contact: Tanya J Lehky, M.D. (301) 496-7428 lehkyt@ninds.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Tanya J Lehky, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier: NCT01900132     History of Changes
Other Study ID Numbers: 130165, 13-N-0165
Study First Received: July 11, 2013
Last Updated: June 6, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Electrophysiology
Neuromuscular Disease

Additional relevant MeSH terms:
Neuromuscular Diseases
Motor Neuron Disease
Nervous System Diseases
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on September 18, 2014