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Trial record 19 of 5226 for:    neuromuscular disease

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

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ClinicalTrials.gov Identifier: NCT01900132
Recruitment Status : Recruiting
First Posted : July 16, 2013
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Brief Summary:

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 or disease
Neuromuscular Disease Motor Neuron Disease Inherited Neuromuscular Conditions Inherited Neuropathies

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 150 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 3 hours 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.


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Study Type : Observational
Estimated Enrollment : 275 participants
Observational Model: Other
Time Perspective: Other
Official Title: Electrical Impedance Myography: Exploratory Studies in Normal Subjects and Patients With Neuromuscular Disorders
Actual Study Start Date : June 6, 2013
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023


Group/Cohort
Normal Volunteers
Healthy volunteers for establishing techniques and normative values
Patients with neuromuscular disorders
Patients for gaining a better understanding of the ability of EIM



Primary Outcome Measures :
  1. Utility of EIM as outcome measure [ Time Frame: 01/01/23 ]
    Primary objectives: The primary objective is to gain experience in the use of EIM device in the evaluation of neuromuscular disease. Wewill initially evaluate healthy volunteers. When we are competent with a standard protocol for evaluating subjects, we will expand toevaluate subjects with neuromuscular disease. Eventually, we would like to incorporate the EIM as a type of biomarker for different neuromuscular disorders and develop it as a tool for clinical trials though this is beyond the scope of this protocol.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
1. Healthy volunteers@@@2. Patients with neuromuscular disorders that are being seen at NIH by any protocol.
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.

NIH Employees: NIH employees and staff may participate, however EMG Section, OCD, NINDS, employees may not participate.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01900132


Contacts
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Contact: Candida Silva (301) 496-8295 candida.silva@nih.gov
Contact: Tanya J Lehky, M.D. (301) 496-7428 lehkyt@ninds.nih.gov

Locations
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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 Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Tanya J Lehky, M.D. National Institute of Neurological Disorders and Stroke (NINDS)

Additional Information:
Publications:
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Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT01900132     History of Changes
Other Study ID Numbers: 130165
13-N-0165
First Posted: July 16, 2013    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 24, 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
Electrophysiology
Neuromuscular Disease
Additional relevant MeSH terms:
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Neuromuscular Diseases
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Nervous System Diseases
Neurodegenerative Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases