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NCT Number: NCT00600795

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

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

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Key information

Conditions

Normal Pressure Hydrocephalus Bone Diseases Bone Diseases, Developmental Brain Diseases Camurati-Engelmann Syndrome Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hydrocephalus Hydrocephalus, Normal Pressure Musculoskeletal Diseases Nervous System Diseases Osteochondrodysplasias

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

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:

  • Correlate CSF levels of TGF-b1 with the clinical response of patients diagnosed with NPH to VPS placement.
  • Correlate CSF levels of TGF-b1 with optimal VPS pressure settings.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Normal Pressure Hydrocephalus

Exclusion criteria

  • Patients not diagnosed with Normal Pressure Hydrocephalus

Treatment and study plan

CSF collection

Other

CSF collection at time of VPS insertion

Primary outcomes

  1. TGF beta-1 levels

    Time frame: Time of Surgery

  2. Mini-mental status exam

    Time frame: Pre-operative, 3 and 12 months post-operatively

  3. Modified barthel index

    Time frame: Pre-operative, 3 and 12 months post-operatively

  4. Tinetti mobility assessment

    Time frame: Pre-operative, 3 and 12 months post-operatively

Secondary outcomes

  1. Programmable shunt setting

    Time frame: Pre-operative, 3 and 12 months post-operatively

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jan 25, 2008
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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