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

Completed

• Conditions: Normal Pressure Hydrocephalus
• Interventions: Other: CSF collection

• Registration Number: NCT00600795
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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

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 Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-07
• Study First Submitted QC: 2008-01-14
• Study First Posted: 2008-01-25
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-30
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Diagnosis of Normal Pressure Hydrocephalus

Exclusion Criteria

• Patients not diagnosed with Normal Pressure Hydrocephalus

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	CSF collection	Patients diagnosed with Normal Pressure Hydrocephalus

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Programmable shunt setting	Pre-operative, 3 and 12 months post-operatively

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States