STEGA-MRI for Brain Connectivity in Hand Movement

No longer recruiting at 1 trial location

Overseen By Summer Fletcher

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Chronic pain, Schizophrenia, Neurological disorders, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify which brain regions assist in skillful movement with the left, non-dominant hand. Participants will complete a drawing task inside an MRI machine to analyze brain activity using STEGA-MRI, a specialized MRI technique. The trial seeks right-handed adults who can speak and read English, including those with specific right-hand injuries and typical controls. It may suit individuals with long-term injuries to the right hand, arm, or shoulder who struggle with writing. As an unphased study, this trial provides a unique opportunity to advance scientific understanding without the limitations of traditional clinical trial phases.

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 might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that STEGA-MRI is safe for brain connectivity studies?

Research shows that the STEGA-MRI treatment is primarily a specialized type of MRI scan. MRI scans are widely used in medicine and are generally safe for most individuals. The STEGA-MRI aims to make these scans faster and clearer. Studies on similar MRI technologies have shown they typically don't cause harm or discomfort, and people generally tolerate them well.

The STEGA-MRI is neither a drug nor a surgery, so it doesn't have side effects like those treatments might. Instead, it enhances the process of capturing brain images. If someone has had an MRI before, this will feel quite similar. The main difference is that the scan might be quicker and the images clearer. As always, discussing any concerns with the research team is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the STEGA-MRI for brain connectivity in hand movement because it offers a unique way to explore how our brain networks are involved in motor tasks. Unlike traditional methods that focus on physical therapy or medication to improve hand movement, STEGA-MRI uses advanced imaging techniques to provide real-time insights into brain activity while performing precise drawing tasks. This approach could lead to a deeper understanding of brain function, potentially opening up new avenues for diagnosing and treating movement disorders.

What evidence suggests that STEGA-MRI is effective for studying brain connectivity in hand movement?

Research shows that STEGA-MRI, a special type of MRI, might help researchers understand how different brain parts work together, especially when using the left non-dominant hand. This trial involves participants performing a precision drawing task during fMRI scanning with STEGA-MRI. This technique quickly captures brain activity, allowing scientists to observe how different brain areas connect during specific tasks. Although direct proof that STEGA-MRI improves understanding of brain connections for hand movement is lacking, its faster scanning process could provide clear images of brain function. Early findings from other studies suggest that this imaging can help identify brain connections in people with various conditions, potentially aiding in understanding brain functions related to movement. ^{1 2 6 7 8}

Who Is on the Research Team?

Benjamin A Philip, PhD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 who primarily use their right hand, speak and read English, can fit in an MRI machine, and have had a chronic nerve injury on the right side for at least 6 months. It's not suitable for those who don't meet these specific conditions.

Inclusion Criteria

My condition involves my hand, arm, or shoulder.

I can fit into a 60 cm wide scanner.

My injury occurred over 6 months ago.

Exclusion Criteria

Uncorrected visual impairment that interferes with ability to see drawings in MRI

I may be excluded from certain parts of the study but not necessarily the whole study.

I have had an amputation of part or all of my thumb, index, or middle finger.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Study Visit

Participants complete surveys and perform movement tasks inside and outside an MRI scanner. Some participants receive transcranial magnetic stimulation (TMS).

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the study visit

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• STEGA-MRI

Trial Overview

The study uses STEGA-MRI to explore how the brain adapts to allow skillful movement of the left non-dominant hand after a person has suffered from a peripheral nerve injury on the right side.

How Is the Trial Designed?

Group I: Movement task Experimental Treatment 1 Intervention

All participants perform the STEGA-MRI (standardized tracing evaluation \& grapheme assessment - MRI) precision drawing task during fMRI scanning. Motor assessments outside the MRI do not qualify as interventions.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

A new three-dimensional fMRI method allows for effective brain imaging on standard 1.5-T scanners without needing extra equipment, making it more accessible for research and clinical use.

This method successfully detected significant increases in brain activity in the primary motor cortex during motor tasks, such as finger tapping, in all subjects tested, demonstrating its efficacy in mapping brain function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-dimensional functional magnetic resonance imaging of human brain on a clinical 1.5-T scanner. van Gelderen, P., Ramsey, NF., Liu, G., et al.[2019]

A new MRI technique for isotropic diffusion mapping provides high-speed imaging (within 559 msec) that is less affected by common issues like magnetic field inhomogeneities and chemical shifts, making it more reliable than traditional echo-planar imaging (EPI).

This method allows for detailed imaging of the brain in healthy subjects with high resolution (2.0 x 2.0 mm) and can produce isotropic diffusion-weighted images and ADC maps, while avoiding regional signal losses and geometric distortions, although it has about half the signal-to-noise ratio compared to EPI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid isotropic diffusion mapping without susceptibility artifacts: whole brain studies using diffusion-weighted single-shot STEAM MR imaging. Nolte, UG., Finsterbusch, J., Frahm, J.[2019]

In a study of 102 participants with active deep brain stimulation (DBS) systems, no short- or long-term adverse events were reported during MRI scans at both 1.5 T and 3 T, indicating that DBS patients can safely undergo MRI procedures.

While DBS hardware caused some imaging artifacts, these only obscured a small portion of the brain (1.4% at 1.5 T and 2.1% at 3 T), primarily affecting areas near the electrode contacts, which suggests that MRI can still provide useful information in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional MRI Safety and Artifacts during Deep Brain Stimulation: Experience in 102 Patients. Boutet, A., Rashid, T., Hancu, I., et al.[2020]

The new method for correcting off-resonance in spiral real-time MRI significantly improves the sharpness of images depicting vocal tract articulators during speech production, particularly at air-tissue boundaries like the upper lip and tongue.

In simulations and in vivo tests, the method proved effective for spiral readout durations up to 5 ms at 1.5T, enhancing the quality of MRI images used to study how we produce speech.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic off-resonance correction for spiral real-time MRI of speech. Lim, Y., Lingala, SG., Narayanan, SS., et al.[2020]

A study involving 12 Parkinson's disease patients demonstrated that 7 Tesla MRI can provide high-quality images with minimal distortion in central brain regions, making it a viable option for surgical planning in deep brain stimulation (DBS).

The analysis showed that the distances between anatomical landmarks on 1.5 T and 7 T MRIs were less than one voxel, indicating successful alignment and suggesting that 7 T MRI can enhance the precision of targeting structures like the subthalamic nucleus (STN) during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of using ultra-high field (7 T) MRI for clinical surgical targeting. Duchin, Y., Abosch, A., Yacoub, E., et al.[2021]

Using a 1.5-T magnetic resonance imager, researchers found that hand and tongue movements resulted in a 3%-8% increase in signal intensity in the motor and sensory cortices of nine volunteers, indicating active brain regions during these tasks.

The study successfully mapped these signal changes onto anatomical images, revealing that the highest signal intensity during hand movements was located near the central sulcus, which is crucial for motor control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional mapping of human motor cortical activation with conventional MR imaging at 1.5 T. Cao, Y., Towle, VL., Levin, DN., et al.[2019]

Real-time MRI (RT-MRI) of the wrist using a high-performance 0.55T system is feasible, providing images with temporal resolutions under 100 ms, which allows for better visualization of wrist motion and pathology.

The study demonstrated that RT-MRI can effectively assess dynamic wrist instability with low distortion and artifacts, and it can be complemented by static MRI for a comprehensive evaluation of wrist anatomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time MRI of the moving wrist at 0.55 tesla. Chaudhari, AJ., Lim, Y., Cui, SX., et al.[2023]

MRI can be safely performed on patients with implanted neurostimulators, as demonstrated in a study involving 38 patients and 50 MRI examinations, with no adverse effects reported during the procedures.

The study found no heat induction in the neurostimulator hardware and no changes in device parameters, indicating that the induced voltages measured during MRI did not pose a risk to patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging with implanted neurostimulators: an in vitro and in vivo study. Tronnier, VM., Staubert, A., Hähnel, S., et al.[2019]

The study assessed the safety of combining intracranial electroencephalography (icEEG) with functional magnetic resonance imaging (fMRI) in a clinical setting, finding that RF-induced heating of electrodes remained below the 1°C safety limit during a 70-minute session.

No significant risks were identified regarding electrode movement or induced voltage, indicating that icEEG-fMRI can be safely performed, although high specific absorption ratio sequences like fast spin echo (FSE) should be avoided to minimize heating risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Safety of Simultaneous Intracranial Electroencephalography and Functional Magnetic Resonance Imaging Acquisition Using a 3 Tesla Magnetic Resonance Imaging Scanner. Fujita, Y., Khoo, HM., Hirayama, M., et al.[2022]

The novel imaging technique improves high-resolution diffusion tensor imaging by dynamically correcting for image artifacts caused by variations in the magnetic field and motion, enhancing the accuracy of the images.

This method significantly reduces local blurring artifacts and increases the spatial accuracy and fractional anisotropy of the estimated diffusion tensors, making it a promising advancement in medical imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic and inherent B0 correction for DTI using stimulated echo spiral imaging. Avram, AV., Guidon, A., Truong, TK., et al.[2021]

The study presents the first MR-compatible multichannel silicon chronic microelectrode system designed for safe recording and stimulation of the central nervous system in animal models, specifically tested on guinea pigs.

The final design minimizes risks such as tissue damage and image artifacts during MRI scans, ensuring good image quality and safety while maintaining functionality for neural recordings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance compatibility of multichannel silicon microelectrode systems for neural recording and stimulation: design criteria, tests, and recommendations. Martínez Santiesteban, FM., Swanson, SD., Noll, DC., et al.[2009]

The newly developed PITA-MDD technique effectively detects and corrects motion artifacts in diffusion MRI, significantly improving image quality during brain and tongue imaging.

By re-acquiring motion-corrupted images, the PITA-MDD technique enhances the accuracy of diffusion parameter estimates, leading to better reconstruction of fiber tracts that would otherwise be distorted by motion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective motion detection and re-acquisition in diffusion MRI using a phase image-based method-Application to brain and tongue imaging. Liang, X., Su, P., Patil, SG., et al.[2022]

Recent advancements in MRI technology allow for real-time functional imaging of brain activity, enabling the collection of images at rates of 10 frames per second or faster.

This method enhances the ability to detect changes in cerebral blood flow associated with neural activity, providing a more immediate understanding of brain function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time functional magnetic resonance imaging. Cohen, MS.[2007]

A new MRI-compatible microdrive was developed to deliver precise electrical microstimulation to specific brain regions while minimizing imaging artifacts, validated through an EM-coupled fMRI study with a macaque monkey.

This microdrive allows for easy insertion, removal, and repositioning of electrodes, making it a versatile tool for future neuroscience research, including neuronal recordings and targeted drug delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI Compatible, Customizable, and 3D-Printable Microdrive for Neuroscience Research. Baeg, E., Doudlah, R., Swader, R., et al.[2023]

Citations

1.

spintechmri.com

spintechmri.com/stage/

Stage

STAGE™ reduces the time for MRI brain protocols up to 30% for your most common procedures, adding an extra 90–120 minutes of MRI scan time per day.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05207878

Interhemispheric Connectivity and Compensation

The goal of this study is to determine which parts of the brain make it possible for some people to move skillfully with their left non-dominant hand. Detailed ...

3.

spintechmri.com

spintechmri.com/

SpinTech MRI: Home

Faster scans, greater throughput. STAGE™ reduces the time for MRI brain protocols up to 30% for your most common procedures, adding an extra 90–120 minutes of ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7541582/

Acute-stage MRI Cerebral Oxygen Consumption ...

For the MRI data, four rats showed motion after the 156-min dynamic scan and six rats completed all dynamic scans, which ended after the 172-min scan. Table ...

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0730725X24000018

Strategically Acquired Gradient Echo (STAGE) Imaging ...

The concept was explained and tested using simulations and brain STAGE data for healthy controls and Parkinson's patients. •. In general, the SNR can be ...

6.

cultivate-md.com

cultivate-md.com/spintech/

SpinTech MRI

SpinTech MRI has created a range of software that provides groundbreaking improvements for MRI brain scans.

7.

pubs.rsna.org

pubs.rsna.org/doi/full/10.1148/radiol.2021203071

Susceptibility-weighted Imaging: Technical Essentials and ...

Susceptibility-weighted imaging is an increasingly important adjunct in diagnosing a variety of neurologic diseases and provides a powerful tool to depict and ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11437990/

Dual stage MRI image restoration based on blind spot ...

We have developed a deep learning-based two-stage model to address noise issues in medical MRI images. This method not only successfully reduces noise signals.