NCT00714636

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 14, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2017

Enrollment Period

2 years

First QC Date

July 10, 2008

Last Update Submit

March 7, 2017

Conditions

Keywords

Amyotrophic Lateral SclerosisCerebrospinal FluidNeurodegenerative DiseaseMotor Neuron DiseaseAutonomic Nervous SystemNeurodegenerative DiseasesMovement Disorders

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Anyone who is not undergoing a lumbar puncture for other reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MDA/ALS Center of Hope

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Cerebrospinal Fluid from Lumbar Puncture.

MeSH Terms

Conditions

Amyotrophic Lateral SclerosisNeurodegenerative DiseasesMotor Neuron DiseaseMovement Disorders

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Terry Heiman-Patterson, MD

    MDA/ALS Center of Hope

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2008

First Posted

July 14, 2008

Study Start

October 1, 2006

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

March 9, 2017

Record last verified: 2017-03

Locations