The Miami Project to Cure Paralysis at the University of Miami Miller School of Medicine Selected as U.S. Site for Neuralink Clinical Trial
Landmark study aims to enable paralyzed patients to use their own thoughts to control external devices through a brain-computer interface.
The Miami Project to Cure Paralysis and the Department of Neurological Surgery at the University of Miami 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.
“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 Institute for Neural Engineering 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 and orthopedics and rehabilitation
• Co-investigator Allan Levi, M.D., Ph.D., professor and chair of neurological surgery
• Co-investigator Michael Ivan, M.D., associate professor of neurological surgery
• Co-investigator 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.
“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, 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.
Tags: Department of Neurological Surgery, Dr. Allan D. Levi, Dr. Jonathan Jagid, Dr. Michael Ivan, Dr. W. Dalton Dietrich III, neurological surgery, spinal cord injuries, technology, The Miami Project to Cure Paralysis