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Trial record 20 of 148 for:    Hydrocephalus

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
  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:


Further study details as provided by Vanderbilt University Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Programmable shunt setting [ Time Frame: Pre-operative, 3 and 12 months post-operatively ]

Biospecimen Retention:   Samples Without DNA
CSF

Enrollment: 21
Study Start Date: January 2008
Study Completion Date: June 2011
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00600795


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
Principal Investigator: Noel Tulipan, M.D. Vanderbilt University Medical Center
  More Information

Responsible Party: Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00600795     History of Changes
Other Study ID Numbers: 070875
First Submitted: January 7, 2008
First Posted: January 25, 2008
Last Update Posted: April 4, 2017
Last Verified: March 2017

Keywords provided by Vanderbilt University Medical Center:
NPH
TGF-beta

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