# Accelerating Dissemination of Implantable Neurotechnology for Clinical Research

> **NIH NIH U24** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2023 · $727,043

## Abstract

Summary
Invasive neurostimulation is an established technique in the therapy of movement disorders and epilepsy, and
shows promise for amelioration of psychiatric and cognitive disorders. Recently, several implantable
neurostimulation hardware platforms have begun to incorporate sensing of cortical and subcortical field
potential activity, with the capability for wireless streaming from the internal device to external computers over
years. These high temporal and spatial resolution signals may be used for discovering the circuit basis of brain
disorders, developing new therapies rationally derived from circuit analysis, and developing adaptive (feedback
controlled) neurostimulation paradigms in which the device auto-adjusts according to changing brain needs.
The most recent “second generation” implantable devices, such as Summit RC+S (Medtronic), have
substantially improved capabilities and offer great flexibility for novel uses, at the expense of increased
complexity. However, effective use of this and related platforms requires academic investigators to develop
previously unfamiliar capabilities, including programming of the desired device functions using an “application
programming interface”, and documenting the performance and validation of software according to FDA
device regulations. While many BRAIN Initiative funded grants intend to use these second generation
bidirectional interfaces, the four institutions on this proposal, working together, are the only groups that have
surmounted the technical and regulatory barriers to launching clinical protocols with second generation sensing
devices. We have formed the “Open Mind” neural communications consortium to share technical and
regulatory infrastructure with each other and with new investigators, and begun to disseminate this knowledge
at open meetings for new investigators, at the April 2018 and 2019 Brain Initiative Meetings. Through this
proposal, we will greatly expand these technology dissemination activities, to provide investigators with
elements critical to the launch of their own clinical studies: A “turnkey” user interface to get started that
includes open source software elements for neural sensing at home and for adaptive stimulation, and a
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. Our 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). This consortium will facilitate already funded proposals, as well as entry of new
investigators, in the rapidly evolving ecosystem of implantable wireless neural interfaces. Two new clinical
teams have al...

## Key facts

- **NIH application ID:** 10689290
- **Project number:** 5U24NS113637-04
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** David Allenson Borton
- **Activity code:** U24 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $727,043
- **Award type:** 5
- **Project period:** 2020-08-15 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10689290

## Citation

> US National Institutes of Health, RePORTER application 10689290, Accelerating Dissemination of Implantable Neurotechnology for Clinical Research (5U24NS113637-04). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10689290. Licensed CC0.

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