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Magnetic Resonance Elastography for Hydrocephalus
N/A
Waitlist Available
Led By Keith D Paulsen, PhD
Research Sponsored by Dartmouth-Hitchcock Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new magnetic resonance technique to see if it can help diagnose normal pressure hydrocephalus without needing invasive procedures.
Who is the study for?
This trial is for adults over 21 with adult onset hydrocephalus, which includes conditions like normal pressure hydrocephalus. Participants should have symptoms such as memory issues, urinary incontinence, or walking problems and enlarged ventricles on brain scans. It's not for those with pacemakers, pregnancy, severe organ dysfunction or diseases that make surgery too risky.
What is being tested?
The study tests a new MRI technique called magnetic resonance elastography (MRE) to see if it can better identify hydrocephalus compared to standard MRI by looking for unique patterns in the brain that indicate the disease.
What are the potential side effects?
Since MRE is a diagnostic imaging technique similar to regular MRIs but measuring tissue stiffness, side effects are minimal but may include discomfort from lying still during the scan or loud noises from the machine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean shear modulus
Secondary study objectives
Pre-operative (and pre-drain placement) shear modulus in the experimental group will be compared with various assessments of clinical improvement after VP shunting.
Side effects data
From 2010 Phase 1 trial • 10 Patients • NCT0089623310%
Red blood cells urine positive
10%
Muscle soreness
10%
Nephrolithiasis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Magnetic Resonance Elastography (MRE)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: MREExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MRE
2009
Completed Phase 1
~330
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Who is running the clinical trial?
Dartmouth-Hitchcock Medical CenterLead Sponsor
537 Previous Clinical Trials
2,539,681 Total Patients Enrolled
2 Trials studying Hydrocephalus
100 Patients Enrolled for Hydrocephalus
National Institute for Biomedical Imaging and Bioengineering (NIBIB)NIH
93 Previous Clinical Trials
20,257 Total Patients Enrolled
1 Trials studying Hydrocephalus
434 Patients Enrolled for Hydrocephalus
Keith D Paulsen, PhDPrincipal InvestigatorDartmouth College
1 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are older than 21 years old.You have a device like a neuro-stimulator or a cardiac pacemaker implanted in your body.You have a known blood clotting problem or a major problem with one of your organs.You have advanced congestive heart failure.You need oxygen for a lung disease, have severe liver disease, need dialysis for kidney failure, or have a condition that makes elective surgery unsafe.You have been diagnosed with hydrocephalus that started in adulthood.You have experienced memory loss, urinary incontinence, or trouble walking that is getting worse.Your brain scan shows enlarged spaces in certain parts of your brain.
Research Study Groups:
This trial has the following groups:- Group 1: MRE
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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