What is the BrainGate?
The BrainGate™ Neural Interface System is an investigational assistive device designed by Cyberkinetics, Inc. of Foxboro, MA. It is intended to give severely paralyzed patients a permanent, direct brain-computer interface for the purpose of controlling of a computer.

A thin sensor the size of an aspirin is implanted on the brain’s surface to monitor the signals that control muscles. The sensor is connected by wires to a small pedestal on the scalp. This pedestal allows the BrainGate computer to be connected to the brain by a fiberoptic cable. The System processes the brain signals, which may allow people to control the cursor on a computer screen by thinking.

The BrainGate System has never been used in people before. Dr. Jon Mukand will be an investigator in a pilot study being sponsored by Cyberkinetics, and the study site is the Sargent Rehabilitation Center. The research study is subject to the rules of the Federal government (FDA) and will be overseen by the New England Institutional Review Board.

What is the purpose of the study?
The purpose is to evaluate the safety of the device in humans as well as the ability of patients to control a computer cursor with the BrainGate.

What are the origins of the BrainGate device?
The BrainGate is the culmination of 10 years of research in the laboratory of Dr. John Donoghue, who is the chairman of the Neuroscience Department at Brown University and Chief Scientific Officer for Cyberkinetics. In conjunction with RI Hospital neurosurgeon, Dr. Gerhard Friehs, he did studies of the BrainGate in monkeys and proved that they were able to control a cursor on a computer monitor with their thoughts. These researchers co-founded Cyberkinetics, so that the BrainGate could be further evaluated in human clinical studies.

Who can enroll in the study?
Patients must be 18 to 60 years old and quadriplegic (unable to use the arms and hands). The protocol for this pilot study allows for only 5 subjects to receive the BrainGate. A detailed screening evaluation will be done to ensure that patients meet the study requirements. This involves a medical history, a mental status exam, a physical exam, an EKG, chest x-ray, brain CT scan, and some blood tests.

How does the surgery work?
There will be two surgeries, one to implant the BrainGate and one to remove it. Before surgery, there will be several precautionary measures in order to prevent infection; patients will have daily baths with antimicrobial soap and take antibiotics. In addition, MRI scans will be done to find the best place on the brain for the sensor.

Under sterile conditions and general anesthesia, Dr. Friehs will drill a small hole into the skull and implant the sensor using the same methods as in the monkey studies. Patients will receive post-surgical care including a CT scan, some blood tests, and wound care in the hospital for 1 to 5 days after surgery.

After surgery, Dr. Jon Mukand (or one of the study doctors) will see the patients at least once a week for six weeks, then monthly and as needed. A nurse will also check the patients regularly and Dr. Jon Mukand will always carry a 24-hour pager.

The skin around the pedestal will need to be carefully monitored during the study. Detailed instructions will be provided so that the patient’s daily care provider can help with skin care. After the skin has healed, testing will begin.

Can patients opt out of the study?
Patients can change their mind about participating, and quit the study at any point in time. If requested by the study doctor, the Sponsor, or the patient’s primary doctor, patients may be taken out of the study and request to have the BrainGate System removed. Also, if patients have problems with the BrainGate sensor or if it has stopped working, the sensor may need to be removed. It will definitely be removed at the end of the study.

How long does the study last?
Participation in this study is a major commitment. The device is used in the home and the Study staff will go there for the convenience of the patients. Dr. Jon Mukand will make an effort to do most of the required visits in the home setting. The study will last for about 13 months. Training will be done about one day per week for a total of 40 days of device testing over the next year. The number of visits may go up or down slightly depending on progress in the study. Visits will last at least 2 hours and may be as long as 8 hours. A cart with a computer, monitors and testing equipment will be kept in the home during the study. At first, the operators will adjust the BrainGate to read the signals from the brain. Then patients will be trained to use the BrainGate to try to move the cursor. Once this testing is done, patients may be asked to try to do more tests.

What happens at the end of the study?
The current plan is for the sensor to be surgically removed and the skull/scalp will be repaired for an optimal appearance. Cyberkinetics may extend the research with a new study and study patients will be given the opportunity to enroll, if eligible. However, there is no guarantee that a new study will be done, or that current patients will be eligible for another study. Of course, we will try to give preference to patients in the present study.

What are the study costs?
The sponsor, Cyberkinetics, Inc. will be responsible for all study-related costs, including the BrainGate System, tests, surgery, and transportation as well as any additional medical expenses required by the study.

What are the possible complications and risks?
During the monkey studies, there was no indication that the sensor damaged the brain or impaired brain functioning. Surgery and use of the BrainGate System involve possible complications and risks. The possible risks related to surgery include: infection, bleeding, stroke, pain, brain swelling, changes in muscle control in the neck or head, fever, seizures, skin problems, headaches, and reaction to anesthesia.

As with any surgery under general anesthesia and involving the brain, there is a small but definite risk of death. None of the monkeys have died due to complications from the BrainGate, and recent data showed only one treatable skin infection in eight implants.

Why should I enter this study?
The possible benefits of this study are to allow people with disabilities to control a computer cursor with their thoughts. It is unknown if the System will work and how well it will work. Cyberkinetics hopes that new versions of the BrainGate Systems will become much smaller and may even be wireless. The patients in this pilot study may be making a major contribution to improving the independence of disabled people. Eventually, the BrainGate may be used to surf the Internet, control environmental control units, and control robotics.

What about confidentiality?
All records from this study will be treated as private health care records, and will be kept confidential. Patients will be asked to sign a release form to send information to agencies as well as the FDA, and the Institutional Review Board.

How do I get more information?
Dr. Jon Mukand may be reached at (401) 886-6600, pager (401) 357-2619. Visit Cyberkinetics on the web at: www.cyberkineticsinc.com

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Last Revised: May 17, 2004