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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 years or older
Suspected or confirmed diagnosis of hydrocephalus from Penn referring physician
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 60 minutes
Awards & highlights
Study Summary
This trial is testing whether a portable, low field strength MRI system is feasible and acceptable to use in an outpatient setting, and whether it provides diagnostic information comparable to that of standard clinical MRI or CT scans.
Who is the study for?
This trial is for adults over 18 with suspected or confirmed hydrocephalus or other neurological disorders, as determined by a Penn physician. Participants must be scheduled for standard brain imaging on the same day as the Hyperfine MRI scan and able to give informed consent. It's not suitable for individuals with certain metal implants, uncontrolled seizures, severe claustrophobia, weight over 400lbs, pregnant women, or those unable to follow study procedures.Check my eligibility
What is being tested?
The trial tests a portable MRI system called Hyperfine in outpatients needing brain scans due to hydrocephalus or other neurological issues. The goal is to see if this low field strength MRI can be used conveniently in an outpatient setting and how well it compares with standard CT/MRI scans done on the same day.See study design
What are the potential side effects?
Since the intervention involves only non-invasive imaging using a portable MRI machine (Hyperfine), there are no direct side effects like you would expect from medication. However, patients may experience discomfort similar to that of regular MRIs such as loud noises during scanning or feelings of claustrophobia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My doctor suspects or has confirmed I have hydrocephalus.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 60 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 60 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hydrocephalus
Presence of other important imaging findings
Quantitative ventricular volumes
Trial Design
2Treatment groups
Experimental Treatment
Group I: Outpatients with other known or suspected neurological conditionExperimental Treatment1 Intervention
Group II: Outpatients with known or suspected hydrocephalusExperimental Treatment1 Intervention
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,002 Previous Clinical Trials
42,880,899 Total Patients Enrolled
1 Trials studying Hydrocephalus
2 Patients Enrolled for Hydrocephalus
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.You are afraid of being in small or enclosed spaces.I have a history of seizures that are not controlled.You have a neurological disorder that your doctor at Penn has identified or suspects.You cannot have an MRI scan if you have certain metal implants in your body, such as a pacemaker or surgical clips.My weight is at least 400lbs (181.4kg).My doctor suspects or has confirmed I have hydrocephalus.
Research Study Groups:
This trial has the following groups:- Group 1: Outpatients with known or suspected hydrocephalus
- Group 2: Outpatients with other known or suspected neurological condition
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.
How many study participants are currently being monitored in this investigation?
"Affirmative. Clinicaltrials.gov suggests that this clinical trial is actively recruiting, with the initial posting occurring on June 28th 2019 and an update taking place July 11th 2022. This trail seeks to recruit 100 patients from a single site."
Answered by AI
Are there still openings in this experiment open to participants?
"Clinicialtrials.gov reports that this research project is actively enlisting participants, having been first listed on June 28th 2019 and recently updated on July 11th 2022."
Answered by AI
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