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

Trial Summary

What is the purpose of this trial?

Participants with known or suspected hydrocephalus will receive brain scans using the Hyperfine, low field strength, portable, magnetic resonance imaging (MRI) system in addition to their scheduled outpatient standard of care clinical computed tomography (CT) or MRI scan. The purpose of this pilot study is to evaluate the feasibility and acceptability of using the Hyperfine system in an outpatient setting and to compare its diagnostic performance to standard clinical imaging. Outpatients with other known or suspected neurological disorders or conditions prompting routine clinical brain imaging with MRI or CT will also be enrolled and the diagnostic performance of low field scans compared to that of the same day standard of care clinical imaging.

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 data supports the idea that Portable MRI for Hydrocephalus is an effective treatment?

The available research shows that Portable MRI, specifically low-field MRI, is effective for hydrocephalus treatment because it provides a safer alternative to traditional CT scans, which expose patients to high levels of radiation. It is particularly useful in developing countries where access to conventional MRI is limited due to cost and infrastructure challenges. The studies highlight that Portable MRI can be used for planning and managing hydrocephalus treatment, offering sufficient image quality to distinguish between brain and fluid, which is crucial for treatment decisions. Additionally, its affordability and portability make it a practical solution in resource-limited settings, improving access to necessary brain imaging. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Hyperfine MRI scan, Hyperfine Swoop Portable MRI, Swoop Portable MR Imaging System for hydrocephalus?

Research shows that portable, low-field MRI systems, like the Hyperfine Swoop, can provide effective brain imaging for conditions such as hydrocephalus, especially in resource-limited settings. These systems are affordable, portable, and can offer sufficient image quality for treatment planning, making them a valuable tool for diagnosing and managing hydrocephalus. ^{1 2 3 4 5}

What safety data exists for the Portable MRI for Hydrocephalus?

The provided research does not contain any safety data related to the Portable MRI for Hydrocephalus, Hyperfine MRI scan, Hyperfine Swoop Portable MRI, or Swoop Portable MR Imaging System. The studies focus on auditory brainstem response, hearing screening, and audiologic monitoring, which are unrelated to the safety of portable MRI systems. ^{6 7 8 9 10}

Is the Hyperfine MRI scan a promising treatment for Hydrocephalus?

Yes, the Hyperfine MRI scan is a promising treatment for Hydrocephalus. It is portable and affordable, making it accessible in areas with limited medical resources. This technology can help diagnose and plan treatment for Hydrocephalus, especially in regions where traditional MRI machines are scarce. ^{1 2 4 5 11}

How does the Hyperfine MRI scan treatment for hydrocephalus differ from other treatments?

The Hyperfine MRI scan is unique because it is a portable, low-field MRI system that can be used outside of traditional hospital settings, making it more accessible and affordable, especially in areas with limited medical resources. Unlike conventional MRI machines, it does not require cryogenics or high power, allowing it to be used in resource-limited settings for conditions like hydrocephalus. ^{1 2 4 5 11}

Eligibility Criteria

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

I am 18 years old or older.

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

Informed consent obtained from patient or legally authorized representative

Exclusion Criteria

Pregnancy

Inability or suspected inability to comply with the study procedures

You are afraid of being in small or enclosed spaces.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

Brain imaging with portable low-field MRI. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

The use of quick-brain magnetic resonance imaging in the evaluation of shunt-treated hydrocephalus. [2005]

4. Germany pubmed.ncbi.nlm.nih.gov

Design of a sustainable prepolarizing magnetic resonance imaging system for infant hydrocephalus. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

An Unmatched Radio Frequency Chain for Low-Field Magnetic Resonance Imaging. [2022]

6. Norway pubmed.ncbi.nlm.nih.gov

Automated auditory brainstem response in neonatal hearing screening. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Validation of a new TEOAE-AABR device for newborn hearing screening. [2019]

8. India pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

Assessing the Brighton Collaboration Case Definition of Sensorineural Hearing Loss in Ghana. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Audiologic monitoring for potential ototoxicity in a phase I clinical trial of a new glycopeptide antibiotic. [2020]

11. England pubmed.ncbi.nlm.nih.gov

A portable scanner for magnetic resonance imaging of the brain. [2022]