Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001185
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Study of Post-Polio Syndrome
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Post-Polio Motor Neuron Disease Clinical Virological and Immunological Studies
Status:
COMPLETED
Status Verified Date:
2003-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Polio or poliomyelitis is the disease caused by the poliovirus The virus attacks cells in the spinal cord and causes symptoms of fever sore throat headache vomiting and stiffness of the neck Patients with polio can have long-term weakness of muscles as a result of the damaged cells in the spinal cord Occasionally patients that recover from the disease can experience a relapse of muscle weakness This can occur as long as 25-35 years after first having polio The condition is called post-polio syndrome
Not all nerve cells in the spinal cord are damaged by the poliovirus Some nerve cells remain healthy and take over the work of the damaged cells Researchers believe that the post-polio syndrome may be caused by failure of these overworked nerve cells However what causes these overworked nerve cells to disintegrate is unknown
The purpose of this study is to apply specific scientific tests to answer important questions about the causes and development of the post-polio syndrome Researchers will investigate possible genetic immunologic and physiologic causes of the post-polio syndrome The study itself will not provide therapy for patients with the condition but may lead to the development of therapies in the future
Not all nerve cells in the spinal cord are damaged by the poliovirus Some nerve cells remain healthy and take over the work of the damaged cells Researchers believe that the post-polio syndrome may be caused by failure of these overworked nerve cells However what causes these overworked nerve cells to disintegrate is unknown
The purpose of this study is to apply specific scientific tests to answer important questions about the causes and development of the post-polio syndrome Researchers will investigate possible genetic immunologic and physiologic causes of the post-polio syndrome The study itself will not provide therapy for patients with the condition but may lead to the development of therapies in the future
Detailed Description:
Post-polio syndrome defines the new muscle weaknesses and the variety of new difficulties with daily living that some patients experience 25-35 years after maximum recovery from acute paralytic poliomyelitis The new weakness appears to be due to disintegration of the distal nerve terminals of the surviving motor neurons whose soma has been stressed for years to maintain large motor units via excessive distal sprouting The factors responsible for the disintegration of axonal sprouts and manifestation of the new weakness and fatigue are unknown Whether an immune response to the poliovirus immunogenetic dysimmune or aging factors play a role in the pathogenesis of this process is also unknown
The purpose of this protocol is to apply specific neuromuscular electrophysiological histological virological and immunological tests to answer pertinent questions regarding the pathogenesis of the post-polio syndrome Studied patients will undergo a series of clinical neuromuscular evaluations quantitative muscle testing electromyography including single fiber EMG immunogenetic viral and immunochemical studies in the serum and spinal fluid muscle biopsy and swallowing evaluation Although this is not a therapeutic study the information obtained would help us understand the pathogenetic mechanisms of the new weakness and could help us design possible therapies
The purpose of this protocol is to apply specific neuromuscular electrophysiological histological virological and immunological tests to answer pertinent questions regarding the pathogenesis of the post-polio syndrome Studied patients will undergo a series of clinical neuromuscular evaluations quantitative muscle testing electromyography including single fiber EMG immunogenetic viral and immunochemical studies in the serum and spinal fluid muscle biopsy and swallowing evaluation Although this is not a therapeutic study the information obtained would help us understand the pathogenetic mechanisms of the new weakness and could help us design possible therapies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 82-N-0083 | None | None | None |