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| Sponsor: | Drexel University College of Medicine |
|---|---|
| Collaborator: |
MDA/ALS Center of Hope |
| Information provided by: | Drexel University |
| ClinicalTrials.gov Identifier: | NCT00714636 |
Purpose
The purpose of a CSF repository is to collect samples of spinal fluid from controls and patients with neurologic disorders including but not exclusively ALS, Dementia, CRPS, neuropathies, and other neuromuscular diseases. This CSF repository will allow the use of CSF in biochemical studies of various neurologic diseases. It would also provide a supply of the necessary normal and disease control patients. CSF would be obtained from patients who are undergoing spinal taps for other reasons including diagnosis, treatment, or participation in clinical trials. We are proposing to collect an additional < 3 ml of CSF from a lumbar puncture that is already being performed for diagnostic or therapeutic reasons, in order to store it in our laboratory for use in future research studies. No lumbar punctures will be initiated specifically for this protocol.
| Condition |
|---|
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Amyotrophic Lateral Sclerosis Cerebrospinal Fluid Neurodegenerative Disease Motor Neuron Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | Cerebrospinal Fluid Repository |
Cerebrospinal Fluid from Lumbar Puncture.
| Estimated Enrollment: | 200 |
| Study Start Date: | October 2006 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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ALS
Subjects having either definite or probable ALS by El Escorial Criteria.
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Non-ALS
Subjects not having either definite or probable ALS by El Escorial Criteria.
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The only specific procedures unique to this protocol is the collection of an additional 3ml or less of cerebrospinal fluid from a lumbar puncture already being performed and the collection of clinical information from the patients medical records. Lumbar puncture may be either a research procedure or a standard of care procedure, depending upon the reason for initiating the puncture. We will aliquot the additional fluid into a separate storage container and it will be maintained in the laboratory of Dr. Heiman-Patterson at -70 degrees. Clinical information including age, medical and neurological history, laboratory data, and pathologic information where indicated will be abstracted from the patient chart. All specimens and corresponding clinical information will be labeled with an identification number and sorted by diagnosis. There will be no patient identifying information kept with the specimens. The CSF sample may be used for studies performed by researchers at Drexel University College of Medicine or shared with collaborators. The CSF sample provided will only be used for projects that have approval by the IRB, but subjects will not be notified each time it is used for a study. If CSF sample is still available, consent can be withdrawn at any time by writing a letter to Dr. Heiman-Patterson requesting the withdrawal of the sample.
Researchers will request control and disease specific samples to use in various research studies. There are no DNA studies.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Those undergoing a lumbar puncture for reasons unrelated to this study.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Pennsylvania | |
| MDA/ALS Center of Hope | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | Terry Heiman-Patterson, MD | MDA/ALS Center of Hope |
More Information
| Responsible Party: | Terry Heiman-Patterson, MD, MDA/ALS Center of Hope |
| ClinicalTrials.gov Identifier: | NCT00714636 History of Changes |
| Other Study ID Numbers: | Internal-16262 |
| Study First Received: | July 10, 2008 |
| Last Updated: | June 15, 2010 |
| Health Authority: | United States: Institutional Review Board |
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Amyotrophic Lateral Sclerosis Cerebrospinal Fluid Neurodegenerative Disease Motor Neuron Disease |
Autonomic Nervous System Neurodegenerative Diseases Movement Disorders |
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Amyotrophic Lateral Sclerosis Sclerosis Motor Neuron Disease Neurodegenerative Diseases Spinal Cord Diseases Central Nervous System Diseases |
Nervous System Diseases TDP-43 Proteinopathies Neuromuscular Diseases Proteostasis Deficiencies Metabolic Diseases Pathologic Processes |