Normal Pressure HydrocephalusNCT00600795
Prognostic Value of Transforming Growth Factor-Beta 1 in Normal Pressure Hydrocephalus
An observational study of Normal Pressure Hydrocephalus, run by Vanderbilt University Medical Center at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Normal Pressure Hydrocephalus
- What is being tested?
- CSF collection
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic and neurology clinic
Who may be able to join
- Diagnosis of Normal Pressure Hydrocephalus
Who cannot join
- Patients not diagnosed with Normal Pressure Hydrocephalus
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Correlation of cerebrospinal fluid levels of transforming growth factor beta-1 with functional improvements after insertion of ventriculoperitoneal shunt for normal pressure hydrocephalus
Read the 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:
- 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.
- Conditions
- Normal Pressure Hydrocephalus
- Being tested
- CSF collection
- Keywords
- NPH, TGF-beta
- Medical subject headings
- Hydrocephalus, Normal Pressure, Camurati-Engelmann Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSF collectionOther
CSF collection at time of VPS insertion
| Study group | Role | What they receive |
|---|---|---|
| A | Patients diagnosed with Normal Pressure Hydrocephalus Receives: Other: CSF collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
TGF beta-1 levels
Measured: Time of Surgery
Mini-mental status exam
Measured: Pre-operative, 3 and 12 months post-operatively
Modified barthel index
Measured: Pre-operative, 3 and 12 months post-operatively
Tinetti mobility assessment
Measured: Pre-operative, 3 and 12 months post-operatively
Secondary outcomes (1)
Programmable shunt setting
Measured: Pre-operative, 3 and 12 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Pressure HydrocephalusStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noel Tulipan, M.D., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600795
- Sponsor's protocol ID
- 070875
- Status last verified
- Mar 2017
- First submitted
- 7 Jan 2008
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Transforming Growth Factor-Beta 1 in Normal Pressure Hydrocephalus
- ClinicalTrials.gov ID
- NCT00600795
- Acronym / sponsor ID
- 070875
- Conditions
- Normal Pressure Hydrocephalus
- Keywords
- NPH, TGF-beta
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 25 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Other: CSF collectionPatients diagnosed with Normal Pressure Hydrocephalus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic and neurology clinic
Key inclusion criteria (1 listed)
- Diagnosis of Normal Pressure Hydrocephalus
Key exclusion criteria (1 listed)
- Patients not diagnosed with Normal Pressure Hydrocephalus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSF collectionCSF collection at time of VPS insertion | Other | A |
Primary outcome
TGF beta-1 levels
Time frame: Time of Surgery
Mini-mental status exam
Time frame: Pre-operative, 3 and 12 months post-operatively
Modified barthel index
Time frame: Pre-operative, 3 and 12 months post-operatively
Tinetti mobility assessment
Time frame: Pre-operative, 3 and 12 months post-operatively
1 secondary outcome
Programmable shunt setting
Time frame: Pre-operative, 3 and 12 months post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
Related trials for Normal Pressure Hydrocephalus
Not yet recruitingObservational study
Prediction of Response to Shunt Surgery in Normal Pressure Hydrocephalus Using Radscale and Lumbar Puncture
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Analysis of Cerebrospinal Fluid Dynamics in Normal Pressure Hydrocephalus
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Evaluation of the Safety and Effectiveness of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus
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Examining the Feasibility of Using Pressure Gradient Regulated Automated Cerebral Spinal Fluid Drainage During External Lumbar Drain Trials
NPH (Normal Pressure Hydrocephalus)
RecruitingObservational study
Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus
Hydrocephalus, Normal Pressure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noel Tulipan, M.D. principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal Pressure Hydrocephalus, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TGF beta-1 levels (time frame: Time of Surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.