Rationale and Objective: The goal of this clinical trial is to demonstrate the safety and effectiveness of a fully implanted neuroprosthesis for providing hand and arm function to individuals with a cervical level spinal cord injury (SCI).

Patients to Be Helped: The individuals to be helped in this trial are those with a cervical level SCI. Patients need to be at least 6 months post-injury. Importantly, this system can provide benefit to individuals with chronic SCI and similar systems have been successfully implemented with patients as long as 30 years post-injury.

Potential Clinical Applications, Benefits, and Risks: Subjects in this trial should be able to manipulate objects and perform functional activities that they could not perform before the intervention, and they should be able to perform many tasks more easily and more independently than they could before the intervention. Common tasks that subjects are expected to improve in include: eating with a fork or spoon, writing with a pen, general office tasks, brushing teeth, shaving, using a cell phone, getting money out of a wallet, and embroidery. The proposed research utilizes an implanted medical device, which has risks similar to an implanted pacemaker, including possible device infection or device failure. Based on our past experience with similar systems, these risks are rare (typically <1%) and can be resolved without permanent injury and without permanent loss of function.

Projected Time to Patient-Related Outcome: Subjects begin exercising their paralyzed muscles with the implanted neuroprosthesis 3 weeks after the implant surgery. Training and evaluation in use of the neuroprosthesis typically begins 4 weeks after that, and subjects gain significant function after 1 week of training. In general, subjects continue to improve in their use of the neuroprosthesis for the first 3 to 6 months after training.

Contribution of Advancing the Field of SCI Research: This clinical trial is being conducted within a much larger vision aimed at making a significant, sustainable impact on the treatment of individuals with SCI. Specifically, SCI, with a relatively small market, is often left out of the benefits of medical advances because large potential profits are unlikely to be achieved. Therefore, we have developed an entire strategy that includes both for-profit and non-profit partnerships to ensure the availability of advanced treatment options, particularly implantable neuroprosthetics, to individuals with SCI. The proposed Spinal Cord Injury Research Program Phase II Clinical Trial is a critical piece of this total vision, providing the data necessary to gain the required regulatory approval to proceed to commercial distribution based out of the for-profit/non-profit partnership.