The Miami Project to Cure Paralysis at the University of Miami Miller School of Medicine Selected as a U.S. Site for Neuralink Clinical Trial

The Miami Project to Cure Paralysis and the Department of Neurological Surgery at the University of Miami (UM) Miller School of Medicine have been selected to become the second U.S.-based site for Neuralink’s PRIME Study, an investigational medical device clinical trial for Neuralink’s ground-breaking brain-computer interface.

The Neuralink PRIME (Precise Robotically Implanted Brain-Computer Interface) Study is an early feasibility study to assess the safety and functionality of Neuralink’s N1 Implant, an intracortical brain-computer interface (BCI) implant that establishes a wireless, digital link between the brain and computers. This link is designed to help restore autonomy to people with paralysis by enabling them to control external devices with their thoughts, without the need for wires or physical movement. The study will also evaluate Neuralink’s R1 Robot, a surgical robot that precisely and rapidly places the N1 Implant’s ultra-fine electrode threads within microns of targeted neurons.

The implant procedure will be carried out by Neuralink scientists and a multidisciplinary team of neurosurgeons, neuroscientists and biomedical engineers at The Miami Project and the Miller School of Medicine.

“We are very excited about working with the Neuralink team. This announcement is a testament to our multidisciplinary approach for advancing the latest research in neural interfaces and neurorehabilitation,” said W. Dalton Dietrich, Ph.D., scientific director of The Miami Project to Cure Paralysis, co-director of the University of Miami Neural Engineering Institute and professor of neurological surgery at the Miller School.

The Department of Neurological Surgery team will include UM’s principal investigator of the trial Jonathan Jagid, M.D., professor of clinical neurological surgery, neurology, orthopedics and rehabilitation and co-investigators Allan Levi, M.D., Ph.D., professor and chair of neurological surgery, Michael Ivan, M.D., associate professor of neurological surgery and Seth Tigchelaar, M.D., Ph.D., a Miller School neurosurgery resident. Dr. Tigchelaar will oversee the surgical approaches performed at UHealth Tower, the flagship hospital of UHealth_—University of Miami Health System.

“This study will use the latest technological advances in BCI approaches for improving function and quality of life in individuals living with the consequences of chronic spinal cord injury, as well as amyotrophic lateral sclerosis (ALS),” said Dr. Levi.

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“The Miami Project to Cure Paralysis and the University of Miami are renowned for their pioneering research in neural interfaces for the treatment of debilitating neurological conditions such as spinal cord injury and ALS. We look forward to partnering with them as a site for our PRIME Study,” said DJ Seo, co-founder, president and COO at Neuralink.

For the PRIME Study (NCT06429735), Neuralink is specifically looking for patients who have limited or no ability to use both hands due to cervical spinal cord injury or ALS. Individuals interested in learning whether they may qualify for this trial can join Neuralink’s United States Patient Registry. 

“This collaboration represents another great opportunity to combine our clinical research expertise with the forward-thinking team at Neuralink. We hope this partnership is another significant step in finding meaningful solutions for the millions living with paralysis and other significant motor deficits,” said Marc Buoniconti, president of The Miami Project.

About the University of Miami Leonard M. Miller School of Medicine and The Miami Project to Cure Paralysis – Established in 1952 as Florida’s first medical school, the University of Miami Leonard M. Miller School of Medicine has become a global leader in medical education, research and clinical care. Boasting more than 1,700 faculty members, 48 centers and institutes and 29 clinical and basic science departments, the Miller School is ranked as Florida’s top NIH-funded medical school. Its innovative dual-degree programs, cutting-edge discoveries in genetics, cellular therapeutics and cancer care and commitment to community health underscore its pivotal role in advancing medicine locally and globally. The Miller School continues to pioneer transformative solutions to complex medical challenges, making it a beacon of innovation and excellence in health care.

The Miami Project to Cure Paralysis, a Center of Excellence at the University of Miami, was formed in 1985 to focus on developing new strategies for repairing the nervous system following spinal cord and brain injury, and to improve function and quality of life. The Miami Project research community is currently engaged in a range of discovery, translational and clinical studies and trials for spinal cord and brain injury, as well as neurodegenerative disorders including Alzheimer’s disease, Parkinson’s disease, ALS and MS. In the area of neuromodulation, The Miami Project faculty are conducting clinical studies utilizing brain-computer interface work and different forms of neuromodulation to improve function and quality of life in people living with spinal cord injury and other neurological disorders. To register for The Miami Project’s research studies and clinical trials email [email protected]

About Neuralink – Neuralink was founded by Elon Musk to create a generalized brain interface to restore autonomy to those with unmet medical needs in the near term and unlock human potential in the long term. To learn more about Neuralink, please follow us on X, YouTube, LinkedIn and our blog.