NCT00600795

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2008

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 25, 2008

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

3.4 years

First QC Date

January 7, 2008

Last Update Submit

March 30, 2017

Conditions

Normal Pressure Hydrocephalus

Keywords

NPHTGF-beta

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • Programmable shunt setting

    Pre-operative, 3 and 12 months post-operatively

Study Arms (1)

A

Patients diagnosed with Normal Pressure Hydrocephalus

Other: CSF collection

Interventions

CSF collectionOTHER

CSF collection at time of VPS insertion

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Primary care clinic and neurology clinic

You may qualify if:

  • Diagnosis of Normal Pressure Hydrocephalus

You may not qualify if:

  • Patients not diagnosed with Normal Pressure Hydrocephalus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

CSF

MeSH Terms

Conditions

Hydrocephalus, Normal PressureCamurati-Engelmann Syndrome

Condition Hierarchy (Ancestors)

HydrocephalusBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesOsteochondrodysplasiasBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Noel Tulipan, M.D.

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2008

First Posted

January 25, 2008

Study Start

January 1, 2008

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

April 4, 2017

Record last verified: 2017-03

Locations

US(1)