It’s Go-Time on Subject Recruitment for our Study

Friday 10/30/2015

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When the call came last December from FDA that our investigational device exemption (IDE) study was approved, it launched a flurry of exuberant emails and texts among our engineering and clinical teams, as the virtual high-fives went all around. Approval of our IDE meant that FDA agreed with our assessment that the Networked Neuroprosthesis (NNP) is ready to be evaluated in people, and we can now begin in earnest the work of identifying and screening subjects for the first human implant of this ground-breaking technology.

How we got here

Back in 2011, our team applied to be part of a newly-formed program at FDA called the Early Feasibility Pilot Program, designed to bring innovative medical devices more quickly into clinical trials in the US. In our early interactions with FDA, we clearly got a strong sense of their keen interest in the Networked Neuroprosthesis, and their appreciation for the promise it holds for people with spinal cord injury. We walked away from those early discussions with a much clearer understanding of the requirements we’d need to meet in order to get our clinical trial started. Over the next couple years we focused on completing the verification and validation testing FDA wanted to see in order to prove the basic safety of the system. These included assuring good development of the system software, making sure the system is electrically safe, making sure the system materials are biocompatible in the body, and developing the procedures necessary to assure sterilization. While these verification and validation test results looked good to us, the real arbiter is the FDA, and all these reports became part of the IDE application we submitted in mid- November, 2014.

Our IDE application requested approval to begin studying the NNP in people with cervical level spinal cord injury in order to provide two functions: hand grasp and trunk stability. Subjects in the study would receive the NNP implant with electrodes placed on the muscles in the arm that provide hand grasp, as well as core muscles of the trunk to provide seated stability during reaching tasks. After a training period, they would use the system in normal daily activities at home, work, and play. The study protocol included evaluations of safety and performance of both the hand and trunk systems used separately, as well as together. The IDE application itself contained all the testing we had completed to date on the NNP, as well as the study protocol that would be followed to collect data to support device safety and effectiveness, informed consent documents, case report forms, and much more. Within a few days of our submission to the FDA, we received some questions from the agency asking for clarification and more details. Over the course of the next three weeks, we heard from agency experts on electrical safety, electromagnetic compatibility testing, battery technology, sterilization, and biocompatibility. This “interactive review” was fast-paced and thorough: our engineering team worked through weekends to run tests that would address FDA’s questions, and we met almost daily to develop our responses to the agency. Within a mere 30 days we had FDA’s verdict: the IDE was conditionally approved and we could begin our clinical trial in two subjects. Our first critical regulatory hurdle was cleared!

Armed with our IDE approval letter, we rapidly applied for and received approvals from our local Institutional Review Board and the Center for Medicare Services. But because we were limited to only two subjects, we worked over the next few months to complete the remaining conditions that FDA had outlined. This August, we submitted our responses and were pleased to receive full approval for our study in September, including an expansion to ten subjects. We’re excited to have reached this point in the development of the NNP. This approval marks a major milestone that reflects not only on the state of our technology, but also on the strength of our interactions with the FDA.

January 6, 2016 Update

We’ve received a lot of interest by people with SCI who want to take part in this first study. We are currently able to take up to 10 subjects, and it’s important to understand that we have a wait list of over 200 people already. Our study is registered with NIH’s ClinicalTrials.Gov, and you can take a look at the eligibility requirements for it here. If you believe that you or a family member might be eligible for this study, please use the “Contact Us” form to drop us a line.

– Megan Moynahan, Executive Director, Institute for Functional Restoration