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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00600795
First Posted: January 25, 2008
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Vanderbilt University Medical Center
January 7, 2008
January 25, 2008
April 4, 2017
January 2008
June 2011   (Final data collection date for primary outcome measure)
  • TGF beta-1 levels [ Time Frame: Time of Surgery ]
  • Mini-mental status exam [ Time Frame: Pre-operative, 3 and 12 months post-operatively ]
  • Modified barthel index [ Time Frame: Pre-operative, 3 and 12 months post-operatively ]
  • Tinetti mobility assessment [ Time Frame: Pre-operative, 3 and 12 months post-operatively ]
Same as current
Complete list of historical versions of study NCT00600795 on ClinicalTrials.gov Archive Site
Programmable shunt setting [ Time Frame: Pre-operative, 3 and 12 months post-operatively ]
Same as current
Not Provided
Not Provided
 
Prognostic Value of Transforming Growth Factor-Beta 1 in Normal Pressure Hydrocephalus
Prognostic Value of Transforming Growth Factor-Beta 1 in Normal Pressure Hydrocephalus
Correlation of cerebrospinal fluid levels of transforming growth factor beta-1 with functional improvements after insertion of ventriculoperitoneal shunt for normal pressure hydrocephalus

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:

  1. Correlate CSF levels of TGF-b1 with the clinical response of patients diagnosed with NPH to VPS placement.
  2. Correlate CSF levels of TGF-b1 with optimal VPS pressure settings.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
CSF
Probability Sample
Primary care clinic and neurology clinic
Normal Pressure Hydrocephalus
Other: CSF collection
CSF collection at time of VPS insertion
A
Patients diagnosed with Normal Pressure Hydrocephalus
Intervention: Other: CSF collection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
June 2011
June 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of Normal Pressure Hydrocephalus

Exclusion Criteria:

  • Patients not diagnosed with Normal Pressure Hydrocephalus
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00600795
070875
Yes
Not Provided
Not Provided
Vanderbilt University Medical Center
Vanderbilt University Medical Center
Not Provided
Principal Investigator: Noel Tulipan, M.D. Vanderbilt University Medical Center
Vanderbilt University Medical Center
March 2017