HealthyNCT00001201
Evaluation of Neuromuscular Disease
An observational study of Healthy and Neuromuscular Disease, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy, Neuromuscular Disease, Peripheral Nervous System Disease
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1984to Nov 2002
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: Evaluation of Neuromuscular Diseases
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.
Read more
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;
- 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.
Read the 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.
- Keywords
- Nerve Conduction Studies, EMG, Normal Volunteer, Electrophysiology, Peripheral Neuropathies, Myopathies
- Medical subject headings
- Neuromuscular Diseases, Peripheral Nervous System Diseases, Muscular Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startOct 1984
- Study completionNov 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 1,500 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001201
- Sponsor's protocol ID
- 840203
- Other IDs
- 84-N-0203
- Status last verified
- Nov 2002
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
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.
PubMed 7294727Nielsen 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.
PubMed 6322048Pollock 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.
PubMed 6830168
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Neuromuscular Diseases
- ClinicalTrials.gov ID
- NCT00001201
- Acronym / sponsor ID
- 840203
- Keywords
- Nerve Conduction Studies, EMG, Normal Volunteer, Electrophysiology, Peripheral Neuropathies, Myopathies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Oct 1984
- Study completion
- Nov 2002
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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;
- 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.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 7294727Dyck 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.
- Background: PubMed 6322048Nielsen 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.
- Background: PubMed 6830168Pollock 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Neuromuscular Disease, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001201, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.