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

March 30, 2017 updated by: Vanderbilt University Medical Center
Correlation of cerebrospinal fluid levels of transforming growth factor beta-1 with functional improvements after insertion of ventriculoperitoneal shunt for normal pressure hydrocephalus

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Primary care clinic and neurology clinic

Description

Inclusion Criteria:

  • Diagnosis of Normal Pressure Hydrocephalus

Exclusion Criteria:

  • Patients not diagnosed with Normal Pressure Hydrocephalus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Patients diagnosed with Normal Pressure Hydrocephalus
Other: CSF collection
CSF collection at time of VPS insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
TGF beta-1 levels
Time Frame: Time of Surgery
Time of Surgery
Mini-mental status exam
Time Frame: Pre-operative, 3 and 12 months post-operatively
Pre-operative, 3 and 12 months post-operatively
Modified barthel index
Time Frame: Pre-operative, 3 and 12 months post-operatively
Pre-operative, 3 and 12 months post-operatively
Tinetti mobility assessment
Time Frame: Pre-operative, 3 and 12 months post-operatively
Pre-operative, 3 and 12 months post-operatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Programmable shunt setting
Time Frame: Pre-operative, 3 and 12 months post-operatively
Pre-operative, 3 and 12 months post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Investigators

  • Principal Investigator: Noel Tulipan, M.D., Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

January 7, 2008

First Submitted That Met QC Criteria

January 14, 2008

First Posted (Estimate)

January 25, 2008

Study Record Updates

Last Update Posted (Actual)

April 4, 2017

Last Update Submitted That Met QC Criteria

March 30, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 070875

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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