Back to resultsMagnetic Resonance Elastography in Hydrocephalus
Primary Purpose
Hydrocephalus
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRE
Sponsored by
About this trial
This is an interventional diagnostic trial for Hydrocephalus focused on measuring Hydrocephalus
Eligibility Criteria
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
Sites / Locations
- Dartmouth-Hitchcock Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MRE
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary outcomes will compare pre- and post-drain MRE shear moduli with ventricular size and intracranial pressure.
Full Information
NCT ID
NCT02230124
First Posted
August 28, 2014
Last Updated
May 15, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
1. Study Identification
Unique Protocol Identification Number
NCT02230124
Brief Title
Magnetic Resonance Elastography in Hydrocephalus
Official Title
Magnetic Resonance Elastography in Hydrocephalus
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2007 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hydrocephalus
Keywords
Hydrocephalus
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MRE
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
MRE
Primary Outcome Measure Information:
Title
Mean shear modulus
Description
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.
Time Frame
15 Years
Secondary Outcome Measure Information:
Title
Pre-operative (and pre-drain placement) shear modulus in the experimental group will be compared with various assessments of clinical improvement after VP shunting.
Description
Secondary outcomes will compare pre- and post-drain MRE shear moduli with ventricular size and intracranial pressure.
Time Frame
15 Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith D Paulsen, PhD
Organizational Affiliation
Dartmouth College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Magnetic Resonance Elastography in Hydrocephalus
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