An Early Feasibility Study of the ReHAB System (Reconnecting the Hand and Arm to the Brain)
The overall purpose of this trial is to advance development of a novel technological approach to allow individuals with tetraplegia to interact with their environment using their own paralyzed limbs by combining recording of brain activity, brain stimulation to provide sensory feedback, and stimulation of the paralyzed extremities based on neural recordings.
Six years ago, a team of researchers from University Hospitals Cleveland Medical Center and Case Western Reserve University, in collaboration with the BrainGate2 consortium, developed a system of muscle stimulation controlled by a brain-computer interface that allowed a paralyzed person to move his previously immobile arm.
Now, the same group of biomedical pioneers is poised to take the next step, advancing a platform to allow unprecedented reanimation of paralyzed limbs under direct control of the brain.
The upgraded system, called ReHAB (for “Reconnecting the Hand and Arm to the Brain”), uses an extensive array of sensors surgically implanted into different brain areas along with high-density stimulating electrodes placed directly on hand, arm, and shoulder nerves. The researchers believe the new system will give paralyzed people the ability to do more than ever before. They will soon be starting a new clinical trial to evaluate its safety and effectiveness.
About This Study
The purpose of this research study is to examine the feasibility of a system that involves implanting small electrodes in the parts of the brain that control movement and sensation, and combining that with electrodes in the upper arm and shoulder to activate paralyzed muscles of the arm and hand. This system is intended for people with extensive paralysis in their arms. The small electrodes in the brain will be used to attempt to measure intended movements, and the muscles in the arm and hand will be stimulated to attempt to follow those intentions.
The study is a prospective, non-randomized, open-label, exploratory safety/feasibility trial of up to 12 subjects. The Primary Endpoint will be evaluation over the first 13 months after implantation, after which the subjects will have the option of removal of the device or continued participation in a long-term study for an additional 5 years, for a total of up to 73 months.
Detailed program information and criteria available at: https://clinicaltrials.gov/ct2/show/NCT03898804
You may also find more information at ReHABstudy.org
Program Contact: Bill Memberg
Contact Number: (216) 957-3606
Contact Email: firstname.lastname@example.org
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