Magnetic Resonance Elastography in Hydrocephalus

Not Applicable

Active, not recruiting

• Conditions: Hydrocephalus
• Interventions: Device: MRE

• Registration Number: NCT02230124
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-01
• Study First Submitted: 2014-08-28
• Study First Submitted QC: 2014-09-02
• Study First Posted: 2014-09-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-27
• Primary Completion: 2026-12-30
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRE	MRE	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States