Cerebrospinal Fluid Repository

Amyotrophic Lateral Sclerosis Clinical Trial

— CSF  

Official title:

Cerebrospinal Fluid Repository

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00714636
• Other study ID #: Internal-16262
• Status: Completed
• Phase: N/A
• First received: July 10, 2008
• Last updated: March 7, 2017
• Start date: October 2006
• Est. completion date: October 2008

Study information

• Verified date: March 2017
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Cerebrospinal Fluid
• Motor Neuron Disease
• Neurodegenerative Disease
• Neurodegenerative Diseases
• Sclerosis

Locations

Country	Name	City	State
United States	MDA/ALS Center of Hope	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Drexel University College of Medicine	MDA/ALS Center of Hope

Country where clinical trial is conducted

United States,