Skip to main content
Clinical Trials/NCT02230124
NCT02230124
Active, not recruiting
Not Applicable

Magnetic Resonance Elastography in Hydrocephalus

Dartmouth-Hitchcock Medical Center1 site in 1 country35 target enrollmentMarch 1, 2007
ConditionsHydrocephalus

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hydrocephalus
Sponsor
Dartmouth-Hitchcock Medical Center
Enrollment
35
Locations
1
Primary Endpoint
Mean shear modulus
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

The purpose of this project is to assess the utility of a new magnetic resonance technique called magnetic resonance elastography (MRE) in the non-invasive diagnosis of normal pressure hydrocephalus. The investigators hypothesize that MRE produces a unique imaging signature for hydrocephalus that distinguishes the disease from the normal (non-hydrocephalic) but atrophied brain, a distinction not possible with conventional MR imaging studies that are presently available.

Registry
clinicaltrials.gov
Start Date
March 1, 2007
End Date
December 30, 2027
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Keith D. Paulsen

Professor

Dartmouth-Hitchcock Medical Center

Eligibility Criteria

Inclusion Criteria

  • Age \>21;
  • One or more of the following complaints: memory loss/dementia, urinary incontinence, or progressive gait disturbance
  • Ventriculomegaly defined as temporal horn width \>2 mm or a FH:ID ratio\>30% on computed tomography or MRI, where FH is the maximal distance between the frontal horns and ID is the internal diameter from inner table to inner table of the skull at this level (Greenberg)
  • A diagnosis of any adult onset hydrocephalus (NPH, post-traumatic, post-hemorrhagic, obstructive, or idiopathic) will be considered for enrollment in this study

Exclusion Criteria

  • Implanted neuro-stimulator or cardiac pacemaker
  • Known coagulopathy; major organ dysfunction
  • End-stage congestive heart failure
  • Oxygen-dependent pulmonary disease, hepatic cirrhosis, or dialysis- dependent renal failure; or other condition which, according to the assessment of the treating surgeon or anesthesia team
  • Precludes consideration of elective surgery
  • Patients who may be pregnant will be excluded from this study as well

Outcomes

Primary Outcomes

Mean shear modulus

Time Frame: 15 Years

The primary outcome measure will be mean shear modulus determined from pre-operative (and pre-drain placement) MRE in patients who demonstrate clinical improvement with trial CSF drainage versus patients who do not demonstrate improvement.

Secondary Outcomes

  • Pre-operative (and pre-drain placement) shear modulus in the experimental group will be compared with various assessments of clinical improvement after VP shunting.(15 Years)

Study Sites (1)

Loading locations...

Similar Trials