Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-02-02 @ 9:43 PM
Study NCT ID:
NCT00600795
Status:
COMPLETED
Last Update Posted:
2017-04-04
First Post:
2008-01-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic Value of Transforming Growth Factor-Beta 1 in Normal Pressure Hydrocephalus
Sponsor:
Vanderbilt University Medical Center
Organization:
Study Overview
Official Title:
Prognostic Value of Transforming Growth Factor-Beta 1 in Normal Pressure Hydrocephalus
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: