Evaluation of Neuromuscular Disease

Healthy Clinical Trial

Official title:

Evaluation of Neuromuscular Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001201
• Other study ID #: 840203
• Secondary ID: 84-N-0203
• Status: Completed
• Phase: N/A
• First received: November 3, 1999
• Last updated: March 3, 2008
• Start date: October 1984
• Est. completion date: November 2002

Study information

• Verified date: November 2002
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: November 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Healthy
• Nervous System Diseases
• Neuromuscular Disease
• Neuromuscular Diseases
• Peripheral Nervous System Disease
• Peripheral Nervous System Diseases

Locations

Country	Name	City	State
United States	National Institute of Neurological Disorders and Stroke (NINDS)	Bethesda	Maryland

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

References & Publications (3)

Dyck PJ, Oviatt KF, Lambert EH. Intensive evaluation of referred unclassified neuropathies yields improved diagnosis. Ann Neurol. 1981 Sep;10(3):222-6. — View Citation

Nielsen VK. Pathophysiology of hemifacial spasm: I. Ephaptic transmission and ectopic excitation. Neurology. 1984 Apr;34(4):418-26. — View 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. — View Citation