Cerebrospinal Fluid Repository

NCT ID: NCT00714636

Last Updated: 2017-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Amyotrophic Lateral Sclerosis Cerebrospinal Fluid Neurodegenerative Disease Motor Neuron Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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ALS

Subjects having either definite or probable ALS by El Escorial Criteria.

No interventions assigned to this group

Non-ALS

Subjects not having either definite or probable ALS by El Escorial Criteria.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Any person undergoing a diagnostic lumbar puncture with a neurologic illness
* Any person undergoing a lumbar puncture as part of anesthesia
* Any person who is undergoing a lumbar puncture for other research purposes such as clinical trials and who has already consented to the lumbar puncture for that purpose.

Exclusion Criteria

* Anyone who is not undergoing a lumbar puncture for other reasons
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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MDA/ALS Center of Hope

OTHER

Sponsor Role collaborator

Drexel University College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Terry Heiman-Patterson, MD

Role: PRINCIPAL_INVESTIGATOR

MDA/ALS Center of Hope

Locations

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MDA/ALS Center of Hope

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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Internal-16262

Identifier Type: -

Identifier Source: org_study_id

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