U01NS128612

An Ecosystem of Technology and Protocols for Adaptive Neuromodulation Research in Humans - Project Summary/Abstract

Neurological and psychiatric disorders affect millions of people in the United States and worldwide, and produce a third of all healthcare costs. Recent research has produced encouraging evidence that adaptive neuromodulation can induce nervous system plasticity that produces long-lasting improvements in certain neurological disorders such as stroke.

At the same time, it is becoming increasingly clear that the technologies that support these demonstrations remain painfully inadequate and inaccessible for both research and clinical application: current non-invasive technologies are typically imprecise; and current invasive technologies, which are more precise, are currently only available with serious restrictions for human use. Moreover, all of the few existing neuromodulation platforms for human use require substantial expertise in diverse areas of engineering, physiology, and regulatory domains that is not available to most groups.

This lack of availability of sufficiently capable and readily usable neuromodulation technologies greatly impedes the development, application, and optimization of new adaptive protocols for improving symptoms of devastating neurological and psychiatric disorders.

The purpose of the project proposed here is to address this critical issue by developing, validating, and widely sharing with the community an easy-to-use adaptive neuromodulation ecosystem (comprised of technology and protocols) that is optimized for the needs of invasive basic and clinical research. We will validate this ecosystem in a canine model, and disseminate it with appropriate documentation to other scientists and clinicians through three project-related test sites and three workshops.

In accord with this objective, we will:

1. Develop a general-purpose hardware/software neuromodulation platform for invasive neuromodulation research.
2. Develop and validate an ecosystem for adaptive neuromodulation research and clinical application.
3. Disseminate this ecosystem of technologies and protocols.

Achieving these three aims will create, validate, and disseminate the first comprehensive ecosystem that facilitates the conception, development, and clinical application of invasive adaptive neuromodulation protocols. We expect that the availability of this ecosystem will greatly increase activities in basic and clinical neuromodulation research that will lead to new understanding of the neural underpinnings of normal and abnormal function and will thereby accelerate the development of novel adaptive neuromodulation protocols to improve treatment for many devastating neurological disorders.

Mayo Clinic

(1) TO SUPPORT EXTRAMURAL RESEARCH FUNDED BY THE NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE (NINDS) INCLUDING: BASIC RESEARCH THAT EXPLORES THE FUNDAMENTAL STRUCTURE AND FUNCTION OF THE BRAIN AND THE NERVOUS SYSTEM, RESEARCH TO UNDERSTAND THE CAUSES AND ORIGINS OF PATHOLOGICAL CONDITIONS OF THE NERVOUS SYSTEM WITH THE GOAL OF PREVENTING THESE DISORDERS, RESEARCH ON THE NATURAL COURSE OF NEUROLOGICAL DISORDERS, IMPROVED METHODS OF DISEASE PREVENTION, NEW METHODS OF DIAGNOSIS AND TREATMENT, DRUG DEVELOPMENT, DEVELOPMENT OF NEURAL DEVICES, CLINICAL TRIALS, AND RESEARCH TRAINING IN BASIC, TRANSLATIONAL AND CLINICAL NEUROSCIENCE. THE INSTITUTE IS THE LARGEST FUNDER OF BASIC NEUROSCIENCE IN THE US AND SUPPORTS RESEARCH ON TOPICS INCLUDING BUT NOT LIMITED TO: DEVELOPMENT OF THE NERVOUS SYSTEM, INCLUDING NEUROGENESIS AND PROGENITOR CELL BIOLOGY, SIGNAL TRANSDUCTION IN DEVELOPMENT AND PLASTICITY, AND PROGRAMMED CELL DEATH, SYNAPSE FORMATION, FUNCTION, AND PLASTICITY, LEARNING AND MEMORY, CHANNELS, TRANSPORTERS, AND PUMPS, CIRCUIT FORMATION AND MODULATION, BEHAVIORAL AND COGNITIVE NEUROSCIENCE, SENSORIMOTOR LEARNING, INTEGRATION AND EXECUTIVE FUNCTION, NEUROENDOCRINE SYSTEMS, SLEEP AND CIRCADIAN RHYTHMS, AND SENSORY AND MOTOR SYSTEMS. IN ADDITION, THE INSTITUTE SUPPORTS BASIC, TRANSLATIONAL AND CLINICAL STUDIES ON A NUMBER OF DISORDERS OF THE NERVOUS SYSTEM INCLUDING (BUT NOT LIMITED TO): STROKE, TRAUMATIC INJURY TO THE BRAIN, SPINAL CORD AND PERIPHERAL NERVOUS SYSTEM, NEURODEGENERATIVE DISORDERS, MOVEMENT DISORDERS, BRAIN TUMORS, CONVULSIVE DISORDERS, INFECTIOUS DISORDERS OF THE BRAIN AND NERVOUS SYSTEM, IMMUNE DISORDERS OF THE BRAIN AND NERVOUS SYSTEM, INCLUDING MULTIPLE SCLEROSIS, DISORDERS RELATED TO SLEEP, AND PAIN. PROGRAMMATIC AREAS, WHICH ARE PRIMARILY SUPPORTED BY THE DIVISION OF NEUROSCIENCE, ARE ALSO SUPPORTED BY THE DIVISION OF EXTRAMURAL ACTIVITIES, THE DIVISION OF TRANSLATIONAL RESEARCH, THE DIVISION OF CLINICAL RESEARCH, THE OFFICE OF TRAINING AND WORKFORCE DEVELOPMENT, THE OFFICE OF PROGRAMS TO ENHANCE NEUROSCIENCE WORKFORCE DEVELOPMENT, AND THE OFFICE OF INTERNATIONAL ACTIVITIES. (2) TO EXPAND AND IMPROVE THE SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. TO UTILIZE THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM, TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.372 - 21st Century Cures Act - Brain Research through Advancing Innovative Neurotechnologies

National Institute of Neurological Disorders and Stroke (NNDS) [HHS - NIH]

Rochester, Minnesota 559050001 United States

Single Zip Code

BRAIN Initiative: Optimization of Transformative Technologies for Recording and Modulation in the Nervous System (U01 Clinical Trials Not Allowed) (RFA-NS-21-027)

Amendment Since initial award the End Date has been extended from 08/31/26 to 05/31/27 and the total obligations have increased 204% from $1,175,904 to $3,579,014.