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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Vanderbilt University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00600795
First received: January 7, 2008
Last updated: April 1, 2011
Last verified: April 2011

January 7, 2008
April 1, 2011
January 2008
June 2011   (final data collection date for primary outcome measure)
  • 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 ]
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 ] [ Designated as safety issue: No ]
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.
 
Recruiting
50
July 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
Both
18 Years and older
No
Contact: Noel Tulipan, M.D. 615-322-6875 noel.tulipan@Vanderbilt.Edu
Contact: Mayshan Ghiassi, M.D. 615-322-1053 mayshan.ghiassi@Vanderbilt.Edu
United States
 
NCT00600795
070875
Yes
Noel Tulipan, MD, Vanderbilt University Medical Center
Vanderbilt University
Not Provided
Principal Investigator: Noel Tulipan, M.D. Vanderbilt University
Vanderbilt University
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP