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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
History of Changes
  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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prognostic Value of Transforming Growth Factor-Beta 1 in Normal Pressure Hydrocephalus

Resource links provided by NLM:

MedlinePlus related topics: Hydrocephalus
U.S. FDA Resources

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

CSF


Estimated Enrollment: 50
Study Start Date: January 2008
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: June 2011 (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:

  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.
  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: Mayshan Ghiassi, M.D. 615-322-1053 mayshan.ghiassi@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

No publications provided

Responsible Party: Noel Tulipan, MD, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00600795     History of Changes
Other Study ID Numbers: 070875
Study First Received: January 7, 2008
Last Updated: April 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
NPH
TGF-beta

Additional relevant MeSH terms:
Hydrocephalus
Hydrocephalus, Normal Pressure
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Intracranial Hypertension
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013