Collection of Cerebrospinal Fluid in Healthy Children

Terminated

• Conditions: Batten Disease; Late Infantile Neuronal Ceroid Lipofuscinosis
• Interventions: Other: Group 1

• Registration Number: NCT01698229
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

The purpose of this study is to obtain cerebrospinal fluid from healthy children already undergoing a lumbar puncture procedure at New York Presbyterian Hospital, to act as healthy controls when compared to children with late infantile neuronal ceroid lipofuscinosis (LINCL), a fatal neurodegenerative disease.

Detailed Description

obtain cerebrospinal fluid from healthy children already undergoing a lumbar puncture procedure at New York Presbyterian Hospital, to act as healthy controls when compared to children with late infantile neuronal ceroid lipofuscinosis (LINCL), a fatal neurodegenerative disease.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-08-15
• Study First Submitted QC: 2012-09-27
• Study First Posted: 2012-10-02
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-03
• Last Update Posted: 2016-05-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Males and females, ages 2 yrs to 8 yrs
• Children already undergoing a lumbar puncture procedure for clinical or diagnostic purposes

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Exclusion Criteria

• Presence of any significant neurological diseases, as judged by the co-investigators
• Presence of any significant medical conditions including cancer

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Group 1	Study cohort is comprised of healthy children, ages 2yrs - 8yrs, who are already undergoing a lumbar puncture procedure at New York Presbyterian Hospital for clinical or diagnostic purposes.

Primary Outcome Measures

Name	Time	Method
Cerebrospinal fluid (CSF)	1 time point (once)	The primary study endpoint is the metabolic profiling of 32 samples of cerebrospinal fluid from healthy subjects, in comparison to 32 samples of CSF from children with LINCL, to determine whether there are biomarkers found in the cerebrospinal fluid that are associated with LINCL.

Trial Locations

Locations (1)

Weill Cornell Medical College / New York Presbyterian Hospital; 🇺🇸 New York, New York, United States