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.
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.
W. Dalton Dietrich, PhD, scientific director of The Miami Project to Cure Paralysis and co-director of the University of Miami Institute for Neural Engineering and professor of neurological surgery at the Miller School said “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”.
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
“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. Allan D. Levi, Chair of the Department of Neurological Surgery.
“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.
*in the picture Roberta Brambilla Ph.D
She serves as a Associate Professor, Department of Neurological Surgery at The Miami Project and Director, Neuroscience Graduate Program – University of Miami Miller School of Medicine. Dr. Brambilla’s research is understanding the role of neuroinflammation in the pathophysiology of neurological disorders (e.g., multiple sclerosis, spinal cord injury, stroke), with a specific interest in the contribution of glial cells. Dr. Brambilla investigate astrocytes and microglia for their involvement in the neuroinflammatory response to injury, and oligodendrocytes and oligodendrocyte precursor cells for their role in axon myelination, metabolic support of neurons and myelin repair. Dr. Brambilla is also interested in the interaction between the immune system and the central nervous system (CNS), and how innate and adaptive immune responses driven by macrophages, T cells and B cells infiltrating into the CNS during disease influence neurological outcomes. She is a distinguished member of the Miami Scientific Italian Community.
