Magnetic Resonance Elastography in Hydrocephalus

NCT02230124 | Active Not Recruiting

• 2 other identifiers: DMS 20618 FED070293R01EB004632-02
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Hydrocephalus

Keywords

Hydrocephalus

Outcome Measures

Primary Outcomes (1)

• Mean shear modulus

  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.

  15 Years

Secondary Outcomes (1)

• 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

Study Arms (1)

MRE

EXPERIMENTAL

Device: MRE

Interventions

MRE DEVICE

MRE

Eligibility Criteria

• Age: 45 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Keith D Paulsen, PhD

  Dartmouth College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 28, 2014
• First Posted: September 3, 2014
• Study Start: March 1, 2007
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

US (1)