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MRI

Portable MRI for Hydrocephalus

N/A
Recruiting
Research Sponsored by University of Pennsylvania
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
Must not have
History of uncontrolled seizures
Weight greater than or equal to 400lbs (181.4kg)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 60 minutes
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I am 18 years old or older.
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My doctor suspects or has confirmed I have hydrocephalus.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of seizures that are not controlled.
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My weight is at least 400lbs (181.4kg).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 60 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 60 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hydrocephalus
Presence of other important imaging findings
Quantitative ventricular volumes

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,084 Previous Clinical Trials
42,726,433 Total Patients Enrolled
1 Trials studying Hydrocephalus
2 Patients Enrolled for Hydrocephalus

Media Library

Hyperfine MRI scan (MRI) Clinical Trial Eligibility Overview. Trial Name: NCT04436068 — N/A
Hydrocephalus Research Study Groups: Outpatients with known or suspected hydrocephalus, Outpatients with other known or suspected neurological condition
Hydrocephalus Clinical Trial 2023: Hyperfine MRI scan Highlights & Side Effects. Trial Name: NCT04436068 — N/A
Hyperfine MRI scan (MRI) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04436068 — N/A
~15 spots leftby Jan 2026
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