Magnetic Resonance Elastography in Hydrocephalus

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02230124

Enrollment

Registered

2014-09-03

Start date

2007-03-01

Completion date

2027-12-30

Last updated

2025-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hydrocephalus

Keywords

Hydrocephalus

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.

Interventions

DEVICEMRE

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

45 Years to 95 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026