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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00600795

Enrollment

Registered

2008-01-25

Start date

2008-01-31

Completion date

2011-06-30

Last updated

2017-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal Pressure Hydrocephalus

Keywords

NPH, TGF-beta

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.

Interventions

OTHERCSF collection

CSF collection at time of VPS insertion

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of Normal Pressure Hydrocephalus

Exclusion criteria

* Patients not diagnosed with Normal Pressure Hydrocephalus

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Programmable shunt setting	Pre-operative, 3 and 12 months post-operatively

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026