Nashville, Tennessee 37232


Purpose:

Correlation of cerebrospinal fluid levels of transforming growth factor beta-1 with functional improvements after insertion of ventriculoperitoneal shunt for normal pressure hydrocephalus


Study summary:

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.


Criteria:

Inclusion Criteria: - Diagnosis of Normal Pressure Hydrocephalus Exclusion Criteria: - Patients not diagnosed with Normal Pressure Hydrocephalus


Study is Available At:


Original ID:

070875


NCT ID:

NCT00600795


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Vanderbilt University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case-Only, Time Perspective:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

50


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Noel Tulipan, M.D.
Principal Investigator
Vanderbilt University
Primary Contact:Noel Tulipan, M.D.
615-322-6875
noel.tulipan@Vanderbilt.Edu
Backup Contact:Mayshan Ghiassi, M.D.
615-322-1053
mayshan.ghiassi@Vanderbilt.Edu

Study Dates

Start Date:January 2008
Completion Date:July 2011
Completion Type:Anticipated
Primary Completion Date:June 2011
Primary Completion Type:Anticipated
Verification Date:April 2011
Last Changed Date:April 1, 2011
First Received Date:January 7, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:TGF beta-1 levels
Time Frame:Time of Surgery
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Mini-mental status exam
Time Frame:Pre-operative, 3 and 12 months post-operatively
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Modified barthel index
Time Frame:Pre-operative, 3 and 12 months post-operatively
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Tinetti mobility assessment
Time Frame:Pre-operative, 3 and 12 months post-operatively
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Programmable shunt setting
Time Frame:Pre-operative, 3 and 12 months post-operatively
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:CSF collection
Description:CSF collection at time of VPS insertion
Arm Name:A

Study Arms

Study Arm Type:Other
Arm Name:A
Description:Patients diagnosed with Normal Pressure Hydrocephalus

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Vanderbilt University

Samples and Retentions

Sample Retention:Samples Without DNA
Description: CSF
Study Population: Primary care clinic and neurology clinic
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


If you would like to be contacted by the clinical trial representative please fill out the form below.