Magnetic Resonance Elastography in Hydrocephalus
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MRE
|
Device: MRE
|
Outcome Measures
Primary Outcome Measures
- Mean shear modulus [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 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. [15 Years]
Secondary outcomes will compare pre- and post-drain MRE shear moduli with ventricular size and intracranial pressure.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age >21;
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One or more of the following complaints: memory loss/dementia, urinary incontinence, or progressive gait disturbance
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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)
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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:
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Implanted neuro-stimulator or cardiac pacemaker
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Known coagulopathy; major organ dysfunction
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End-stage congestive heart failure
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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
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Precludes consideration of elective surgery
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Patients who may be pregnant will be excluded from this study as well
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
Sponsors and Collaborators
- Dartmouth-Hitchcock Medical Center
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Investigators
- Principal Investigator: Keith D Paulsen, PhD, Dartmouth College
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DMS 20618 FED07029
- 3R01EB004632-02