"While these results are preliminary, I am encouraged that the first study participant has been able to both control a computer cursor and perform useful tasks with the system", stated Jon Mukand, M.D., Ph.D., the investigator for the study based at Sargent Rehabilitation Center. "If this study is successful, the BrainGate System could potentially give paralyzed individuals an unprecedented level of independence with everyday activities such as typing, manoeuvring wheelchairs, and operating other computerized systems such as environmental controls, robotics, and the Internet."
The first participant in the study, Mr. Matthew Nagle, a patient of New England Sinai Hospital and Rehabilitation Center in Stoughton, Massachusetts, stated: "I am feeling well and am using the BrainGate about twice a week. In the past few weeks, I have been able to control my TV using a computer cursor that I can move with my thoughts. I hope that someday I will be able to do even more with the BrainGate, like move my arms with a muscle stimulation device. The Brain Gate has changed my life."
The device used in the study is called the BrainGate Neural Interface System. The investigational BrainGate System provided by Cyberkinetics Neurotechnology Systems Inc., the sponsor of the study, is an outgrowth of research conducted in the lab of Dr. John Donoghue, Ph.D., Chairman of Neuroscience at Brown University, as well as other researchers. The system consists of an internal neural signal sensor and external processors that convert neural signals into an output signal under the person's own control. An approximately three-hour surgery was conducted to implant the sensor portion of the BrainGate on the surface of the brain where thoughts of hand and arm movement originate. After three weeks of post-surgical recovery, the patient began using the BrainGate System where he lives, at New England Sinai Medical Center.
The ongoing pilot feasibility study will enroll up to five quadriplegic individuals, unable to use the arms and legs, between the ages of 18 and 60 who meet the study's selection criteria, which include that the patient be able to verbally communicate. Each participant will undergo surgery in which the sensor portion of the BrainGate neural interface will be implanted on the surface of the primary motor cortex, the portion of the brain responsible for movement.
The two primary goals of the pilot clinical study are to characterize the safety profile of the device and to evaluate the quality, type, and usefulness of neural output control that patients can achieve using thoughts. The study is expected to last for about 13 months for each patient, who will perform tasks with the device including attempting to control the movement of a cursor on a screen with thoughts like imagining movement of the hand or arm to move the cursor toward a specific target. At the end of the study, each patient will undergo another surgery to have the device removed or may have the option to participate in future studies.
Sargent Rehabilitation Center in Warwick, Rhode Island is the first clinical site to be initiated by Cyberkinetics. The Principal Investigator, Dr. Jon Mukand is also on the faculty of Brown University, Boston University and Tufts University. The surgery to implant the sensor was conducted at Rhode Island Hospital in Providence by Gerhard M. Friehs, M.D., Ph.D., director of functional neurosurgery and associate professor of clinical neurosciences at Brown Medical School.
Sargent Rehabilitation Center specializes in outpatient medical rehabilitation and education services for children and adults with disabilities with the goal of moving clients toward maximum community access to education, daily living and employment. Sargent offers a Paediatric Institute, Diagnostic Center, Adult Neuro-Rehabilitation Center and Consultant Group. The Center's vision is "achieving the extraordinary in rehabilitating human potential".