Magnetic Resonance Elastography in Hydrocephalus

Hydrocephalus Clinical Trial

Official title:

Magnetic Resonance Elastography in Hydrocephalus

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02230124
• Other study ID #: DMS 20618 FED07029
• Secondary ID: 3R01EB004632-02
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2007
• Est. completion date: December 30, 2025

Study information

• Verified date: May 2023
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Hydrocephalus

Intervention

Device:
• MRE

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	15 Years