MR Evaluation for Brain Health

Overseen By Suson (Sue) Walsh

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Non-MRI compatible devices, Pregnancy, others

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

Compensation: Varies

Number of Visits: 2

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new MRI method to better understand how cerebral spinal fluid (CSF) moves in the brain. By observing CSF behavior, researchers hope to improve the diagnosis and understanding of brain diseases like Alzheimer's and hydrocephalus, a condition where fluid accumulates in the brain. The trial seeks healthy individuals without brain-related issues and those with suspected CSF problems or cognitive impairments, such as memory or balance issues. Participants must not have metal implants and must not be pregnant, as confirmed by a urine pregnancy test.

As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance the understanding and diagnosis of brain diseases.

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's best to discuss this with the study team or your doctor.

What prior data suggests that this MR imaging method is safe for detecting CSF flow in the brain?

Research has shown that brain MRIs are generally very safe for most people. Unlike X-rays, MRIs do not use radiation, which is a common concern with other imaging tests. Instead, they use magnets and radio waves to capture images of the brain. As a result, there is no known risk of tissue harm from the scan itself.

However, safety checks are important before the scan. People with metal implants, pacemakers, or certain other medical devices often cannot undergo an MRI. The machine can be loud, but the noise is harmless. Overall, MRIs provide a safe and well-tolerated method for examining brain health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MR brain evaluation because it offers a non-invasive way to assess brain health, which could potentially enhance early detection of neurological issues. Unlike other diagnostic tools, such as CT scans, MRIs don't use ionizing radiation, making them safer for repeated use. Additionally, the MRI's ability to provide detailed images of the brain's structure and function could lead to more accurate diagnoses and personalized treatment plans. This approach could pave the way for better understanding and management of various brain conditions.

What evidence suggests that this MR imaging method is effective for detecting CSF flow in the brain?

Research has shown that Magnetic Resonance Imaging (MRI) effectively detects changes in the brain. It identifies issues related to conditions such as alcoholism and dementia. MRI also predicts recovery prospects after a stroke by assessing brain health indicators. This imaging method produces detailed brain images, linking brain structures with behavior or symptoms. Overall, MRI serves as a powerful tool for diagnosing and understanding brain-related issues. Participants in this trial will undergo MR imaging of the brain to evaluate these aspects of brain health. ^{6 7 8 9 10}

Who Is on the Research Team?

Petrice Cogswell, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for healthy individuals and those with suspected altered CSF dynamics, such as hydrocephalus or cognitive impairments like Alzheimer's. Participants should not have conditions affecting brain function or memory issues. Pregnant women, people needing sedation for MRI, or those with non-MRI compatible devices cannot join.

Inclusion Criteria

Similarly, patients with impaired cognitive function including but not limited to Alzheimer's disease will be referred to Dr. Cogswell by their care team to be included in the study.

I am healthy with no brain function issues or problems with concentration, memory, balance, or coordination.

I am suspected to have a condition affecting the flow of brain fluid, possibly leading to headaches or memory problems.

Exclusion Criteria

You have medical devices that are not safe for MRI scans.

I need medication to help me stay calm or asleep.

I have normal pressure hydrocephalus and have not had a shunt placed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

MR Imaging

Participants undergo MR imaging to measure CSF flow and volume, and assess white matter disease

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for any immediate post-imaging effects and data analysis

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MR Brain
• Urine Pregnancy Test

Trial Overview The study is testing a new MR imaging method to observe the flow of cerebrospinal fluid (CSF) in the brain. This could improve diagnosis and understanding of conditions like Alzheimer's Disease and Hydrocephalus that impact brain function.

How Is the Trial Designed?

Group I: MR brain Experimental Treatment 3 Interventions

Participants will be asked to complete a MRI screening form to check for the presence of metallic implants and materials. People with pacemakers, aneurysm clips, and cochlear implants, or metal/foreign objects in their eyes cannot have an MRI and will not be able to participate in the study. Pre-menopausal females will be asked if they think they may be pregnant. If yes, a urine pregnancy test will be performed. Those who meet eligibility criteria for the study and have agreed to participate will be taken to the MRI suite when MR imaging of the brain will be performed.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

MRI is crucial for diagnosing neurological disorders, especially in cases where CT scans may not provide sufficient information, such as abnormalities in the temporal lobes and subtle inflammatory diseases.

Recent advancements in MRI technology, including improved imaging techniques and the use of contrast agents, have enhanced the speed and effectiveness of brain imaging, making it a more valuable tool in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging of the brain. Wallace, CJ.[2019]

MRI is a safe and high-resolution imaging technique that outperforms cranial ultrasound in detecting brain injury and assessing brain development in neonates, particularly in preterm infants.

Advanced MRI techniques, such as diffusion tensor imaging and functional connectivity, enhance the ability to predict neurodevelopmental outcomes, which can inform parental counseling and early intervention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of neuroimaging in predicting neurodevelopmental outcomes of preterm neonates. Kwon, SH., Vasung, L., Ment, LR., et al.[2016]

Ultrahigh-field magnetic resonance imaging (≥7 T) offers highly detailed and contrast-rich images of brain pathologies, enhancing early diagnosis and treatment monitoring for brain diseases.

Despite its potential for increased sensitivity and specificity in clinical applications, several limitations must be addressed before it can be widely implemented in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrahigh-field magnetic resonance imaging: the clinical potential for anatomy, pathogenesis, diagnosis, and treatment planning in brain disease. van der Kolk, AG., Hendrikse, J., Luijten, PR.[2012]

In a study of 39 patients with elevated beta-hCG levels, magnetic resonance imaging (MRI) showed that primary molar disease is characterized by significantly increased total intrauterine volume and higher prevalence of endometrial distention and masses compared to persistent gestational trophoblastic disease (GTD).

MRI findings were less specific for differentiating between persistent GTD, incomplete abortion, and ectopic pregnancy, but it effectively identified invasive disease in 65% of patients with persistent GTD and high beta-hCG levels, which could influence treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic MR imaging findings in gestational trophoblastic disease, incomplete abortion, and ectopic pregnancy: are they specific? Barton, JW., McCarthy, SM., Kohorn, EI., et al.[2004]

Nuclear magnetic resonance (NMR) imaging has been successfully used in 92 examinations of 62 pregnant women, providing excellent differentiation of maternal and fetal tissues without using ionizing radiation, making it a safe imaging option during pregnancy.

The best quality fetal images were consistently obtained in the third trimester, allowing for detailed visualization of critical structures such as the brain, lungs, and placenta, which is beneficial for monitoring both normal and complicated pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nuclear magnetic resonance imaging--a new look at the fetus. Smith, FW., Kent, C., Abramovich, DR., et al.[2019]

Magnetic resonance imaging (MRI) has shown superior sensitivity in detecting diseases of the central nervous system and heart compared to other imaging techniques, but it has not yet achieved the same level of success in identifying abdominal diseases, including kidney conditions.

Ongoing advancements in MRI technology, such as improvements in hardware, software, and pulse sequences, are expected to enhance its effectiveness in evaluating kidney health and disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging of the kidney. Papanicolaou, N., Hahn, PF., Edelman, RR., et al.[2019]

A study of 40 women assessed the effectiveness of magnetic resonance hysterosalpingography (MR HSG) compared to conventional hysterosalpingography (cHSG) for checking tubal patency, using diagnostic laparoscopy as the gold standard.

The results showed that MR HSG is equally effective as cHSG in identifying blocked or open fallopian tubes, while being less invasive and avoiding radiation exposure, making it a valuable tool in evaluating female infertility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conventional and magnetic resonance hysterosalpingography in assessing tubal patency-A comparative study. Jagannathan, D., Hithaya, F.[2022]

This systematic review aims to compare the diagnostic performance of magnetic resonance hysterosalpingography (MR-HSG) and hysterosalpingosonography for detecting fallopian tubal occlusion in women facing infertility, indicating a thorough evaluation of existing studies.

The findings suggest that MR-HSG may be a valuable alternative diagnostic tool for assessing fallopian tubal occlusion, potentially offering improved diagnostic value over traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparation of magnetic resonance hysterosalpingography and hysterosalpingosonography for the assessment of fallopian tubal occlusion of female infertility: A protocol for systematic review and meta-analysis. Zhang, J., Zhang, X., Bian, J., et al.[2023]

Magnetic resonance imaging (MRI) is likely superior to computed tomography (CT) for detecting and characterizing certain conditions, such as posterior fossa lesions and spinal cord myelopathies, and is particularly useful in multiple sclerosis and guiding complex therapies like brain tumor treatment.

While MRI generally provides higher quality images and is less invasive than some CT procedures, its overall clinical efficacy compared to CT is not consistently superior, and more rigorous studies are needed to validate its effectiveness across various conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging of the brain and spine. Is clinical efficacy established after the first decade? Kent, DL., Larson, EB.[2019]

MRI can provide critical information for diagnosing intracranial hemorrhage in fetuses when ultrasound results are inconclusive, as demonstrated in a case of a fetus with a grade-III hemorrhage at 26 weeks of gestation.

In this case, MRI confirmed the severity of the hemorrhage and indicated a poor prognosis, leading to the decision to induce labor, highlighting the importance of MRI in managing high-risk pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prenatal diagnosis of fetal intracranial hemorrhage at 25 weeks of gestation. Zanders, EH., Buist, FC., van Vugt, JM.[2017]

A new imaging technique called magnetic resonance hysterography (MR-HG) and hysterosalpingography (MR-HSG) using hyperpolarized (3)He has been developed to improve the assessment of the uterine cavity and fallopian tube patency.

Initial tests of this technique were conducted on swine cadavers, indicating its potential for enhanced imaging capabilities in reproductive health diagnostics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance hysterography and hysterosalpingography using hyperpolarized (3)He: demonstration of feasibility in an animal model. Hagspiel, KD., Altes, TA., Mugler, JP., et al.[2019]

In a study of 6,683 pediatric brain MRIs, only 8 cases (0.12-0.52%) showed relevant additional findings when gadolinium-based contrast was used on previously normal scans, indicating minimal diagnostic gain.

The findings suggest that routine use of gadolinium contrast in children with normal pre-contrast MRIs is unnecessary and may pose risks without significant benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do we need gadolinium-based contrast medium for brain magnetic resonance imaging in children? Dünger, D., Krause, M., Gräfe, D., et al.[2018]

Magnetic Resonance Hysterosalpingography (MR HSG) demonstrated a high sensitivity of 95.5% for detecting fallopian tube patency, showing comparable efficacy to conventional hysterosalpingography (HSG) in a study involving 18 rabbit uterine horns.

MR HSG offers advantages such as the absence of ionizing radiation and better visualization of uterine conditions like fibroids and endometriosis, making it a promising alternative for assessing fallopian tube health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR hysterosalpingography in a rabbit model. Lee, FT., Grist, TM., Nelson, KG., et al.[2022]

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