Evaluation of Neuromuscular Disease
Primary Purpose
Healthy, Neuromuscular Disease, Peripheral Nervous System Disease
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Healthy focused on measuring Nerve Conduction Studies, EMG, Normal Volunteer, Electrophysiology, Peripheral Neuropathies, Myopathies
Eligibility Criteria
Patients with disorders of the peripheral nervous system, including neuropathies, myopathies, or defective neuromuscular transmission. Normal age-matched volunteers, including some from within a neurologic population.
Sites / Locations
- National Institute of Neurological Disorders and Stroke (NINDS)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001201
First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
1. Study Identification
Unique Protocol Identification Number
NCT00001201
Brief Title
Evaluation of Neuromuscular Disease
Official Title
Evaluation of Neuromuscular Diseases
Study Type
Observational
2. Study Status
Record Verification Date
November 2002
Overall Recruitment Status
Completed
Study Start Date
October 1984 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2002 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
4. Oversight
5. Study Description
Brief Summary
The peripheral nervous system is the portion of the nervous system outside of the brain and spinal cord. It includes the 12 pairs of cranial nerves, 31 pairs of spinal nerves and their branches, nerves responsible for sensation and maintenance of normal body functions (sympathetic and parasympathetic nerves).
Years of research using clinical examinations, microscopic examinations, and electrophysiology have made the peripheral nervous system the best-studied and most available portion of the nervous system. However, even with all of the extensive studies conducted on the peripheral nervous system, many conditions remain unclassified.
The EMG Laboratory at the NIH concentrates on studying disorders of the peripheral nervous system. This protocol was designed to allow the EMG Laboratory to;
I) Learn more about established diseases of the peripheral nervous system
II) Identify and characterize new diseases of the peripheral nervous system
III) Assess current techniques in the diagnosis of diseases of the peripheral nervous system
IV) Refine old methods and develop new ones for the diagnosis of diseases of the peripheral nervous system.
Detailed Description
Combined with careful clinical examination, electrophysiology and histopathology have rendered the peripheral nervous system the best studied and most accessible level of the nervous system. But even after intensive diagnostic evaluation of peripheral neuropathies in large diagnostic centers, 24 to 70% of disorders remain unclassified. Analogous statistics for disorders of muscle and neuromuscular transmission are not known but probably similar, if not worse. Clearly, detailed diagnostic characterization of disorders of the peripheral nervous system is the first stage in clinical intervention.
Currently, the EMG Laboratory at the NIH offers complete clinical, electrophysiologic, and, when appropriate, pathologic evaluations on all referrals from the other Branches and Institutes. Since these referrals come primarily from within the NIH, most disorders are secondary to other systemic disease. This protocol is designed to extend the services to direct referrals of primary disorders of the peripheral nervous system. The purposes are first, to learn more about established diseases; second, to identify and characterize new diseases; third, to assess current methodologies and technologies; and fourth, to refine old methods and develop new ones. Under this umbrella protocol, individual cases and clinical series can be investigated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Neuromuscular Disease, Peripheral Nervous System Disease
Keywords
Nerve Conduction Studies, EMG, Normal Volunteer, Electrophysiology, Peripheral Neuropathies, Myopathies
7. Study Design
Enrollment
1500 (false)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Patients with disorders of the peripheral nervous system, including neuropathies, myopathies, or defective neuromuscular transmission.
Normal age-matched volunteers, including some from within a neurologic population.
Facility Information:
Facility Name
National Institute of Neurological Disorders and Stroke (NINDS)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
7294727
Citation
Dyck PJ, Oviatt KF, Lambert EH. Intensive evaluation of referred unclassified neuropathies yields improved diagnosis. Ann Neurol. 1981 Sep;10(3):222-6. doi: 10.1002/ana.410100304.
Results Reference
background
PubMed Identifier
6322048
Citation
Nielsen VK. Pathophysiology of hemifacial spasm: I. Ephaptic transmission and ectopic excitation. Neurology. 1984 Apr;34(4):418-26. doi: 10.1212/wnl.34.4.418.
Results Reference
background
PubMed Identifier
6830168
Citation
Pollock M, Nukada H, Taylor P, Donaldson I, Carroll G. Comparison between fascicular and whole sural nerve biopsy. Ann Neurol. 1983 Jan;13(1):65-8. doi: 10.1002/ana.410130114.
Results Reference
background
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Evaluation of Neuromuscular Disease
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