Portable MRI for Hydrocephalus

Overseen By Marisa Sanchez

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Uncontrolled seizures, Claustrophobia, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new portable MRI machine to determine its effectiveness in diagnosing conditions like hydrocephalus (a buildup of fluid in the brain) and other neurological disorders. Participants will receive a scan with this new device, the Hyperfine MRI scan, alongside their regular brain scans. The goal is to assess whether this portable MRI performs as well as standard imaging. Suitable candidates are those already scheduled for a brain scan due to suspected or confirmed neurological issues. As an unphased trial, this study allows participants to contribute to innovative research that could make MRI technology more accessible.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue them, but please confirm with the study team.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Hyperfine MRI scan is safe for use in outpatients with neurological conditions?

Research has shown that the Hyperfine MRI system, known as the Swoop Portable MRI, has received FDA approval for brain scans in people of all ages, indicating it meets strict safety standards. The Swoop uses a weaker magnet than regular MRI machines, which may be safer for individuals sensitive to strong magnetic fields. However, the sources provided do not include specific safety information about its use for hydrocephalus.

This study examines how well the Hyperfine system performs compared to standard imaging. The device's existing use for other brain-related conditions can offer some confidence in its safety for participants in this study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the portable MRI for hydrocephalus because it offers a new way to conveniently and quickly diagnose this condition. Unlike traditional MRI machines, which are large and stationary, the Hyperfine MRI scan is compact and can be used in various settings, including outpatient clinics. This means patients can get the imaging they need without traveling to specialized facilities, potentially speeding up diagnosis and treatment. Additionally, the portable MRI is designed to be more cost-effective, making advanced imaging more accessible to a broader range of patients.

What evidence suggests that the Hyperfine MRI scan is effective for diagnosing hydrocephalus?

Studies have shown that the Hyperfine Swoop portable MRI system can effectively scan the brain for conditions like hydrocephalus. This trial will evaluate the Swoop system's use in two groups: outpatients with known or suspected hydrocephalus and those with other known or suspected neurological conditions. The Swoop system uses a magnet much weaker than those in regular MRIs, yet it can still detect critical brain issues like strokes and bleeding. Research indicates that the Swoop system is faster, with scans taking about 2.5 hours compared to nearly 28 hours for standard MRI machines. Its portability allows for quicker and more flexible imaging, which proves especially useful in emergency and outpatient settings. Initial findings suggest this technology could be a valuable tool for diagnosing and managing brain conditions. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have a neurological disorder that your doctor at Penn has identified or suspects.

Informed consent obtained from patient or legally authorized representative

My doctor suspects or has confirmed I have hydrocephalus.

Exclusion Criteria

Pregnancy

Inability or suspected inability to comply with the study procedures

You are afraid of being in small or enclosed spaces.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo Hyperfine MRI in conjunction with routine clinical imaging to evaluate the feasibility and acceptability of the Hyperfine system

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hyperfine MRI scan

Trial Overview 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.

How Is the Trial Designed?

Group I: Outpatients with other known or suspected neurological condition Experimental Treatment 1 Intervention

Group II: Outpatients with known or suspected hydrocephalus Experimental Treatment 1 Intervention

Hyperfine MRI scan is already approved in United States, European Union, United Kingdom for the following indications:

Approved in United States as Hyperfine Swoop Portable MRI for:

• General brain imaging
• Headaches
• Stroke
• Non-specific muscular weakness
• Encephalopathy
• Coronavirus (Covid-19) related neurological disorders

Approved in European Union as Hyperfine Swoop Portable MRI for:

• General brain imaging
• Headaches
• Stroke
• Non-specific muscular weakness
• Encephalopathy
• Coronavirus (Covid-19) related neurological disorders

Approved in United Kingdom as Hyperfine Swoop Portable MRI for:

• General brain imaging
• Headaches
• Stroke
• Non-specific muscular weakness
• Encephalopathy
• Coronavirus (Covid-19) related neurological disorders

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

Portable, low-field magnetic resonance imagers can enhance the clinical assessment of stroke, providing valuable imaging support in emergency situations.

These devices have the potential to improve access to medical imaging resources, making it easier for more patients to receive timely and effective care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of stroke by portable, low-field MRI: A milestone in medical imaging. Basser, P.[2022]

Portable low-field MRI (LF-MRI) offers enhanced access to neuroimaging outside traditional MRI suites, making it suitable for various clinical situations that conventional MRI cannot easily address.

Recent advancements in noise cancellation, machine learning algorithms, and image enhancement techniques have improved the diagnostic quality of LF-MRI, paving the way for its use in both healthy brain visualization and the detection of neurological conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain imaging with portable low-field MRI. Kimberly, WT., Sorby-Adams, AJ., Webb, AG., et al.[2023]

A new portable MRI scanner prototype, weighing only 122 kg and using a low-field magnet, can produce high-quality brain images without the need for expensive infrastructure or cryogenics.

This scanner has the potential to improve access to brain MRI, especially for critically ill patients, by providing imaging capabilities directly at the point of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A portable scanner for magnetic resonance imaging of the brain. Cooley, CZ., McDaniel, PC., Stockmann, JP., et al.[2022]

In a study of 194 infants with abnormal head sizes in Lagos, Nigeria, microcephalic infants were found to be significantly at risk for sensorineural hearing loss (SNHL), while macrocephalic infants showed no significant risk.

The findings suggest that microcephalic infants should undergo routine hearing screenings, especially in areas where universal newborn hearing screening is not feasible, highlighting the need for further investigation into the causes of abnormal head sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of sensorineural hearing loss in infants with abnormal head size. Olusanya, BO.[2014]

The Brighton Collaboration's case definition for assessing sensorineural hearing loss (SNHL) was successfully applied to 300 patients in Ghana, with 85% of cases assessable and a high consistency (99.3%) in classification among assessors.

The study highlighted that electronic medical records (EMRs) were less effective for assessing SNHL compared to paper records, suggesting that improving EMR documentation, particularly for otoscopy results, could enhance the identification and classification of SNHL cases in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the Brighton Collaboration Case Definition of Sensorineural Hearing Loss in Ghana. Bukari, I., Huang, WT., Issahalq, DM., et al.[2023]

In a phase I clinical trial involving healthy volunteers, the new glycopeptide dalbavancin was evaluated for potential ototoxicity, and no subjects showed any signs of hearing damage after treatment.

The study followed strict FDA regulations and included comprehensive audiologic assessments, confirming that dalbavancin does not cause ototoxic effects, ensuring its safety in this regard.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Audiologic monitoring for potential ototoxicity in a phase I clinical trial of a new glycopeptide antibiotic. Campbell, KC., Kelly, E., Targovnik, N., et al.[2020]

Low-field MRI technology, designed for low-cost and portability, can significantly improve access to brain imaging for conditions like hydrocephalus in low- to middle-income countries, particularly in sub-Saharan Africa.

The innovative use of a low-powered radio frequency chain and affordable materials like chicken wire for shielding demonstrates that effective imaging can be achieved with reduced power consumption and cost, making it a sustainable option for neurological diagnosis in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Unmatched Radio Frequency Chain for Low-Field Magnetic Resonance Imaging. Harper, JR., Zárate, C., Krauch, F., et al.[2022]

The prepolarizing MRI (PMRI) technology has been successfully demonstrated for diagnosing infant hydrocephalus in developing countries, showing that it can operate effectively in unshielded environments with modest spatial resolution requirements.

This low-field MRI system is cost-effective and easy to assemble, making it a promising solution for improving medical imaging access in areas with limited resources, with potential for further enhancements in image quality for broader clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of a sustainable prepolarizing magnetic resonance imaging system for infant hydrocephalus. Obungoloch, J., Harper, JR., Consevage, S., et al.[2021]

The new TEOAE-AABR screening device demonstrated excellent agreement with an established device, achieving a concordance of 0.98 for TEOAE and 0.96 for AABR measurements across 299 ears in a study involving 150 newborns and infants.

This new device significantly reduced screening times, with mean durations of 15.4 seconds for TEOAE and 26.6 seconds for AABR, making it more efficient for use with restless children compared to the established device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of a new TEOAE-AABR device for newborn hearing screening. Neumann, K., Indermark, A.[2019]

Early diagnosis and intervention for severe congenital hearing impairment, ideally before 6 months of age, significantly improves developmental outcomes in children, highlighting the importance of universal screening rather than limiting it to high-risk groups.

The automated auditory brainstem response (AABR) screener is a highly effective tool for hearing screening, with up to 98% agreement with conventional methods, and can be used in various settings, including hospitals and homes, with minimal operator involvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated auditory brainstem response in neonatal hearing screening. van Straaten, HL.[2020]

Single-shot fast-spin echo (SSFSE) magnetic resonance imaging (MRI) is a safe, radiation-free alternative to CT scanning for evaluating children with shunt-treated hydrocephalus, significantly reducing exposure to harmful radiation.

SSFSE MRI minimizes movement artifacts and scanning duration, eliminating the need for sedation, making it a more efficient and patient-friendly option for both symptomatic workup and follow-up examinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of quick-brain magnetic resonance imaging in the evaluation of shunt-treated hydrocephalus. Iskandar, BJ., Sansone, JM., Medow, J., et al.[2005]

Citations

1. hyperfinemri.com hyperfinemri.com/

Hyperfine, Inc. and the Swoop® Portable MR Imaging® ... The Swoop system is an AI-powered, portable brain MRI that uses a magnet with a fraction of the field strength used in conventional MRI.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10576557/

Current role of portable MRI in diagnosis of acute ... Benefits of pMRI include timely and accurate detection of major acute neurological pathologies such as stroke and intracranial hemorrhage.

3. clinicaltrialsarena.com clinicaltrialsarena.com/news/hyperfine-swoop-mri-system-trumps-standard-mris-in-interim-study/

Hyperfine's Swoop MRI system trumps standard MRIs in ... Hyperfine revealed data that the Swoop system outperformed conventional MRI in speed, with a median time-to-scan of 2.5 hours compared to 27.7 hours.

4. withpower.com withpower.com/trial/phase-nervous-system-diseases-5-2019-a83c7

Portable MRI for Hydrocephalus · Info for Participants Research shows that portable, low-field MRI systems, like the Hyperfine Swoop, can provide effective brain imaging for conditions such as hydrocephalus, ...

5. investors.hyperfine.io investors.hyperfine.io/news-releases/news-release-details/hyperfine-announces-first-patients-enrolled-prime-study-aimed

Hyperfine Announces First Patients Enrolled in PRIME ... The real-world study will assess the clinical and operational impact of portable MRI across diverse patient types in ED settings.

6. investors.hyperfine.io investors.hyperfine.io/news-releases/news-release-details/hyperfine-swoopr-ai-powered-portable-mri-system-showcased

Hyperfine Swoop® AI-Powered Portable MRI System ... The Swoop® Portable MR Imaging® Systems are U.S. Food and Drug Administration (FDA) cleared for brain imaging of patients of all ages. They ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf25/K250236.pdf

May 30, 2025 Hyperfine, Inc. Christine Kupchick Sr. Manager ... The Swoop System (V2) is portable, ultra-low field MRI device that enables visualization of the internal structures of the head using standard ...