Cerebrospinal Fluid Repository (CSF)

This study has been completed.
Sponsor:
Collaborator:
MDA/ALS Center of Hope
Information provided by:
Drexel University
ClinicalTrials.gov Identifier:
NCT00714636
First received: July 10, 2008
Last updated: June 15, 2010
Last verified: June 2010
  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
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

Resource links provided by NLM:


Further study details as provided by Drexel University:

Biospecimen Retention:   Samples With DNA

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

Detailed Description:

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
Study Population

Those undergoing a lumbar puncture for reasons unrelated to this study.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00714636

Locations
United States, Pennsylvania
MDA/ALS Center of Hope
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Drexel University College of Medicine
MDA/ALS Center of Hope
Investigators
Principal Investigator: Terry Heiman-Patterson, MD MDA/ALS Center of Hope
  More Information

No publications provided

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

Keywords provided by Drexel University:
Amyotrophic Lateral Sclerosis
Cerebrospinal Fluid
Neurodegenerative Disease
Motor Neuron Disease
Autonomic Nervous System
Neurodegenerative Diseases
Movement Disorders

Additional relevant MeSH terms:
Motor Neuron Disease
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Metabolic Diseases
Amyotrophic Lateral Sclerosis
Sclerosis
TDP-43 Proteinopathies
Proteostasis Deficiencies
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014