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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean shear modulus
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.
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)
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
Find a Location
Who is running the clinical trial?
Dartmouth-Hitchcock Medical CenterLead Sponsor
524 Previous Clinical Trials
2,543,304 Total Patients Enrolled
2 Trials studying Hydrocephalus
100 Patients Enrolled for Hydrocephalus
National Institute for Biomedical Imaging and Bioengineering (NIBIB)NIH
89 Previous Clinical Trials
19,749 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment process for this study still ongoing?
"According to clinicaltrials.gov, the application window for this trial closed in February 2022 after first being put up on March 1st 2007. However, 26 other medical studies are currently open and taking participants."
Answered by AI
Does the trial permit elderly individuals to participate?
"This trial is available for adults aged 45 to 95. There are 5 trials that accept minors and 21 studies open to seniors beyond the age of 65."
Answered by AI
Who qualifies for this research project?
"To qualify for this investigation, potential volunteers must have hydrocephalus and be situated between the ages of 45 to 95. Additionally, 35 candidates are needed for enrollment in this trial."
Answered by AI
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