Prognostic Value of Transforming Growth Factor-Beta 1 in Normal Pressure Hydrocephalus - Full Text View

Purpose

Correlation of cerebrospinal fluid levels of transforming growth factor beta-1 with functional improvements after insertion of ventriculoperitoneal shunt for normal pressure hydrocephalus

Condition	Intervention
Normal Pressure Hydrocephalus	Other: CSF collection

MedlinePlus related topics:

Hydrocephalus

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective

Official Title:	Prognostic Value of Transforming Growth Factor-Beta 1 in Normal Pressure Hydrocephalus

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

TGF beta-1 levels [ Time Frame: Time of Surgery ] [ Designated as safety issue: No ]
Mini-mental status exam [ Time Frame: Pre-operative, 3 and 12 months post-operatively ] [ Designated as safety issue: No ]
Modified barthel index [ Time Frame: Pre-operative, 3 and 12 months post-operatively ] [ Designated as safety issue: No ]
Tinetti mobility assessment [ Time Frame: Pre-operative, 3 and 12 months post-operatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Programmable shunt setting [ Time Frame: Pre-operative, 3 and 12 months post-operatively ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

CSF

Estimated Enrollment:	50
Study Start Date:	January 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A Patients diagnosed with Normal Pressure Hydrocephalus	Other: CSF collection CSF collection at time of VPS insertion

Detailed Description:

The goal of this research is to investigate a potential CSF biomarker of NPH as a new tool for both the diagnosis of NPH and prognosis of VPS placement. Transforming growth factor-b1 (TGF-b1) is a signaling molecule involved in three fundamental activities; suppression of cell proliferation, immunosuppression, and deposition of extracellular matrix through promotion of synthesis and inhibition of degradation.8 Previously, TGF-b1 had been implicated in the development of communicating hydrocephalus secondary to pre-term infant intraventricular hemorrhage9 and adult aneurysmal sub-arachnoid hemorrhage.10, 11 Recently, an investigation demonstrated elevated levels of TGF-b1 in patients with shunt-responsive NPH compared to non-NPH patients.12

The specific aims of this research proposal are to:

Correlate CSF levels of TGF-b1 with the clinical response of patients diagnosed with NPH to VPS placement.
Correlate CSF levels of TGF-b1 with optimal VPS pressure settings.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Primary care clinic and neurology clinic

Criteria

Inclusion Criteria:

Diagnosis of Normal Pressure Hydrocephalus

Exclusion Criteria:

Patients not diagnosed with Normal Pressure Hydrocephalus

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600795

Contacts


Contact: Noel Tulipan, M.D.	615-322-6875	noel.tulipan@Vanderbilt.Edu

Contact: David A. Sun, M.D., Ph.D.	615-322-1053	david.sun@Vanderbilt.Edu

Locations


United States, Tennessee
	Vanderbilt University Medical Center	Recruiting
	Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Vanderbilt University

Investigators


Principal Investigator:	Noel Tulipan, M.D.	Vanderbilt University

More Information

Responsible Party:	Vanderbilt University Medical Center ( Noel Tulipan, MD )
Study ID Numbers:	070875
First Received:	January 7, 2008
Last Updated:	January 14, 2008
ClinicalTrials.gov Identifier:	NCT00600795
Health Authority:	United States: Institutional Review Board