The “Open Mind” neural communications consortium was formed to accelerate cooperation and innovation in the use of implantable neurostimulation hardware platforms. These next generation devices incorporate sensing of cortical and subcortical field potential activity, with the capability for wireless streaming from the internal device to external computers over years. Our founding team represents the major clinical areas of interest in neuromodulation: movement disorders (UCSF), epilepsy (Mayo Clinic), and psychiatry (Brown/Baylor), and includes experts in the design and dissemination of implantable devices (Oxford), and in neuroethics. This consortium will facilitate already funded proposals, as well as entry of new investigators, in the rapidly evolving ecosystem of implantable wireless neural interfaces.
Our goal is to provide investigators with critical elements to the launch of their own clinical studies: A “turnkey” user interface to get started, a library of more sophisticated, open source software elements for neural sensing at home paired with peripheral monitors, and streamlined regulatory pathway for FDA approval of investigational protocols, which we call the “Open Source Quality Management System”. We will disseminate education and resources through biannual workshops and a web-based library of regulatory documents, software, and the Quality Management System*.
Many medical device manufacturers that provide investigational devices for research use require contracts between institutions and their company. These contracts cover intellectual property rights and govern what information must be kept private. See the NIH [public private partnership]() for more detailed examples of such contracts. In order to comply with these contracts, the OpenMind GitHub code repository is stripped of all proprietary or confidential (as per individual contracts) information, and it is our goal to maintain this as a public resource.
It is critical, however, that each user that has existing agreements with medical device manufactures not contribute confidential or proprietary information or data to the public repository.
We have other resources, such as IDE documents, consent documents and QMS examples on the OSF website.
We are eager to expand the scientific and clinical research community aiming to understand the brain and lower the barrier of entry for new teams. Currently, we require an existing agreement with the device manufacture with whom you work, but this will soon change. Please follow this link to submit an Open Mind invitation form.
We aim to build device-agnostic tools that enable broader adoption of neurotechnology. Please reach out to one of the consortium leaders (links below) to discuss further.
On-going clinical study IDE Documentation – OSF website
OpenMind Software – Github development and deployment repositories (please note that we will soon be reorganizing the GitHub repositories to streamline external access points and agile organization)
NIH Public-Private Partnership – https://braininitiative.nih.gov/brain-programs/public-private-partnerships
For access to private resources, please submit an inquiry via this form.