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

Normal Pressure Hydrocephalus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00600795
• Other study ID #: 070875
• Status: Completed
• Phase: N/A
• First received: January 7, 2008
• Last updated: March 30, 2017
• Start date: January 2008
• Est. completion date: June 2011

Study information

• Verified date: March 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of Normal Pressure Hydrocephalus

Exclusion Criteria:

• Patients not diagnosed with Normal Pressure Hydrocephalus

Related Conditions & MeSH terms

• Hydrocephalus
• Hydrocephalus, Normal Pressure
• Normal Pressure Hydrocephalus

Intervention

Other:
• CSF collection
CSF collection at time of VPS insertion

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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