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ClinicalTrials.gov Identifier: NCT02230124
Recruitment Status :
Active, not recruiting
First Posted : September 3, 2014
Last Update Posted : May 23, 2018
Dartmouth-Hitchcock Medical Center
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):
Keith D. Paulsen, Dartmouth-Hitchcock Medical Center
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.
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 Outcome Measures :
Pre-operative (and pre-drain placement) shear modulus in the experimental group will be compared with various assessments of clinical improvement after VP shunting. [ Time Frame: 15 Years ]
Secondary outcomes will compare pre- and post-drain MRE shear moduli with ventricular size and intracranial pressure.
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Ages Eligible for Study:
45 Years to 95 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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