Magnetic Resonance Elastography in Hydrocephalus

NCT ID: NCT02230124

Last Updated: 2025-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-01

Study Completion Date

2027-12-30

Brief Summary

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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

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Conditions

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Hydrocephalus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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MRE

Group Type EXPERIMENTAL

MRE

Intervention Type DEVICE

Interventions

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MRE

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Keith D. Paulsen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Keith D Paulsen, PhD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth College

Locations

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Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Countries

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United States

Other Identifiers

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3R01EB004632-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DMS 20618 FED07029

Identifier Type: -

Identifier Source: org_study_id

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