Electrical Impedance Myography: Exploratory Studies in Healthy People and People With Neuromuscular Disorders
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 2 - 120 |
| Updated: | 2/13/2019 |
| Start Date: | June 6, 2013 |
| End Date: | January 1, 2023 |
| Contact: | Candida Silva |
| Email: | candida.silva@nih.gov |
| Phone: | (301) 496-8295 |
Electrical Impedance Myography: Exploratory Studies in Normal Subjects and Patients With Neuromuscular Disorders
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.
- 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.
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.
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.
- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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