Researchers move closer to advancing spinal cord injury care

Following a $13.48 million dollar award from the defense department, a team of engineers and surgeons from Johns Hopkins Medicine have published their first proof-of-concept study that shows temporarily implanting a tiny ultrasonic device into the location of a spinal cord injury can be feasible, safe and potentially useful. These findings, which mark an early midpoint in a multitiered research journey to develop and study how the device could be used in clinical care, published today in Science Advances.

“When the biology of spinal cord injury is local, our devices should also be able to track and treat local physiology,” says Amir Manbachi, Ph.D., the principal investigator and an associate professor of neurosurgery and biomedical engineering at the Johns Hopkins University School of Medicine.

The device that Manbachi and researchers developed and studied, which is called Multimodal Ultrasound System for Injury Care (MUSIC), is designed to enhance feedback about what is happening at and around the site of injury following surgery and to support clinical decisions about care when a patient is recovering in the intensive care unit.

Manbachi explains that the ultimate goal of developing and studying the device is to identify a way to support people while they are in the hospital and minimize risks for complications, such as experiencing a stroke, becoming blind or losing additional control of movement, that they may face with recovering from a spinal cord injury.

To achieve this, the device was designed to double as a “mobile MRI” that could alleviate the need to move immobile patients in the days following their recovery, while providing on-demand and as-needed feedback to medical teams, as opposed to single points in time.

The device has a dual nature of diagnostic ultrasound (sonography) and therapeutic ultrasound (physical therapy):

The diagnostic/imaging aspect of the device provides real-time insight about blood flow and changes surrounding the spinal cord injury and enables analysis of other measures, such as spinal fluids and excess fluid accumulation, how a person is responding to medication and what is happening outside of the injured area, which can provide insight about how well a person is healing. This type of real-time detection in the days and weeks after surgery could provide instant feedback to medical teams, while helping to personalize treatment decisions.

The therapeutic ultrasound (also known as focused ultrasound) is the more futuristic and exploratory aspect of the device that has been studied for its potential ability to identify and respond to changes in blood flow at and around the site of the injury (when blood flowing through the small vessels around the affected area drops below or above acceptable levels).

This ultrasound device, which received FDA Breakthrough Device Designation in 2023, is the size of a small band-aid and can be placed over the spinal cord at the site of injury during the expected surgery following spinal cord injury. This publication reports the first proof-of-concept study in animals to show that MUSIC was able to be temporarily implanted and provide real-time feedback about blood flow and imaging around the site where it is located.

“Timing is critical for recovery,” says Nicholas Theodore, M.D., a former neurosurgeon at Johns Hopkins and a current adjunct professor of medicine, who created the device with Manbachi. “This research represents a fusion of multiple industries, disciplines and applications that we envision has the power to fine-tune and personalize the care that a person receives following their surgery, which could support and improve their health outcomes months and years later.”

This research follows prior work in the Johns Hopkins Holistic Electrical, ultrasonic and Physiological Interventions Unburdening those with Spinal cord injury (HEPIUS) Innovation Lab and will enable the investigators to continue to study how the device can be used and optimized to receive feedback about blood flow, identify changes to the tissues and spine and monitor other activities that take place near the site of injury. These outcomes will continue to be investigated through preclinical research studies.

The team designed the device with the goal of helping people across a variety of ages and life stages. This could range from soldiers recovering from wounds on the battlefield to children or adults affected by severe car crashes, falls or sports injuries. An estimated 18,000 spinal cord injuries occur in the United States each year with vehicle accidents being the most common.

To learn about the MUSIC device, visit https://youtube.com/watch?v=EYYBgKGEuO0.

To learn about the Department of Defense Advanced Research Projects Agency (DARPA) award, visit https://hopkinsmedicine.org/news/newsroom/news-releases/2020/10/1348m-awarded-to-johns-hopkins-scientists-to-develop-implantable-ultrasound-devices-for-patients-with-spinal-cord-injury.  

Additional co-authors include Max Kerensky, Siddharth Krishnan, Ruixing Liang, Kelley Kempski Leadingham, Victor Quiroz, Joshua Punnoose, Constantin Smit, Denis Routkevitch, Avisha Kumar, A. Daniel Davidar, Leonard Steger, Carly Weber-Levine, Kelly Jiang, Meghana Bhimreddy, Stuart Bauer, Angelica Lopez, Kayla Robinson, Arjun Menta, Abdul Karim Ghaith, Patrick Kramer, Andrew Hersh, Haley Abramson, Ali Mohammadabadi, John Theodore, Osamah Zmily, Ritvik Jillala, Vikas Vattipally, David Kopala, Siavash Barough, Mohammad Hossein Amini, Jonathan Maltz, Francisco Chavez, Kyle Morrison, Laura Roy, Ian Suk, Ryan Lee, Betty Tyler, Mark Luciano, Nitish Thakor and Joshua Doloff.

Research funding

The research is mainly funded by the Department of Defense (N660012024075) under its DARPA Bridging the Gap (BG+) program as well as the National Institutes of Health (NIH) Blueprint funding (grant 5U54EB033650-04, subaward GR0244157-S11), DARPA’s Entrepreneur Embedded Initiative (EEI) award (contract HR001126CE085) and the Maryland Technology Development Corporation (TEDCO)’s Maryland Innovation Initiative (MII) grant.

The authors have also been supported by various federal and state grants, philanthropic funding and with support from Johns Hopkins University. This includes research support from the Johns Hopkins Institute for Clinical and Translational Research (ICTR), which is administered by the National Center for Advancing Translational Sciences (NCATS), part of NIH, and is supported through a clinical research scholars program and award T32 TR004928. Additional support comes from the National Science Foundation (NSF)’s Small Business Technology Transfer award 1938939, NSF graduate fellowships, and NIH awards T32 860 GM136577 and F30 HL68823.

Philanthropic support has also been provided by the Khatib Brain Tumor Center, the Florence D. and Irving J. Sherman M.D. Foundation Trust and the Venable Foundation.

Disclosures

Manbachi has served as a consultant for GE HealthCare, Globus Medical and Longeviti NeuroSolutions. Nicholas Theodore receives royalties from and owns stock in Globus Medical. He is a consultant for Globus Medical and has served on the scientific advisory board for Globus Medical. Manbachi and Nicholas Theodore are inventors of the following patents related to this research: US20230404473AI, US20230371901AI, PCT/US2024/020941, PCT/US2024/028125 and PCT/US2023/028138. (These patents are assigned to Johns Hopkins University and potential commercialization may result in financial benefit to the inventors.) Punnoose is an employee of and owns stock in Globus Medical. Betty Tyler is a stockholder for Peabody Pharmaceuticals, and Ashvattha Therapeutics Inc. has licensed one of her patents.

About Johns Hopkins Medicine

Johns Hopkins Medicine is an $11 billion integrated global health enterprise and one of the leading academic healthcare systems in the United States. It unites the physicians and scientists of the Johns Hopkins University School of Medicine with the organizations, health professionals and facilities of the Johns Hopkins Health System. Diverse and inclusive, Johns Hopkins Medicine educates medical students, scientists, healthcare professionals and the public; conducts biomedical research; and provides patient-centered medicine to prevent, diagnose and treat human illness. Johns Hopkins Medicine has six academic and community hospitals in Maryland, the Washington, D.C., metropolitan region and Florida, including The Johns Hopkins Hospital, which opened in 1889. The organization operates four healthcare and surgery centers, more than six ambulatory surgery centers, and more than 50 primary and specialty care outpatient sites under Johns Hopkins Community Physicians. Johns Hopkins Medicine extends healthcare into the community through Johns Hopkins Care at Home and Johns Hopkins Health Plans, and around the world through Johns Hopkins Medicine International. For information about the enterprise and its research, education and clinical programs, and for the latest health, science and research news, visit hopkinsmedicine.org.