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Implantable Neurostimulators for Control of Oscillatory Brain Networks

Award Number: R01MH123634
ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2020
PERIOD OF PERFORMANCE END DATE: 05/31/2025

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Implantable Neurostimulators for Control of Oscillatory Brain Networks - We propose to develop an implantable brain stimulation system to measure and control oscillatory local field potential (LFP) synchrony within brain networks. Implantable neurotechnologies like deep brain stimulation (DBS) have revolutionized the treatment of movement disorders and epilepsy. DBS has some clinical signal in psychiatry as well, but individual trial results are highly variable. We have argued that this is a target engagement problem – that the high-frequency constant stimulation used in Parkinson’s or other tremor disorders is not the right approach to the circuits of mental illness. Instead, we believe the correct approach is to identify signatures of healthy communication in these circuits/networks, then design stimulation protocols that specifically produce those signatures. LFP synchrony is likely one of those communication signatures. Across multiple domains of cognitive and emotional function, behavioral performance (a read-out of successful network communication) improves when brain regions show synchronous (coherent) LFP oscillations. Further, clinically effective DBS, in movement and psychiatric disorders, is associated with changes in LFP synchrony. Co-PI Widge has developed algorithms that specifically control inter-regional LFP synchrony, by locking electrical stimulation pulses in one region to the phase of an ongoing oscillation in another region. The translational challenge is that efficient, implantable real-time synchrony monitoring and phase-locked stimulation require signal processing capabilities not found in any existing or anticipated device. Co-PI Shoaran has developed power-efficient phase estimation circuits, specifically optimized for DBS- like implants. We propose to combine these approaches. Aims 1 and 2 will develop a new application- specific integrated circuit (ASIC) that integrates Dr. Shoaran’s measurement and neural decoding frameworks with Dr. Widge’s oscillation-control methods. We will validate this circuit’s recording and phase-locking capabilities in vivo in Dr. Widge’s rodent lab. In Aim 3, a world-leading contract implant manufacturer (Cirtec) will integrate that new ASIC into a packaged, implant-ready device ready for large animal safety testing. Cirtec has already developed a DBS prototyping platform optimized to get new therapies more quickly into first-in- human, allowing us to greatly accelerate the path to the clinic and reduce regulatory risk. At the end of 5 years, we will either be ready for that clinical pilot or have only modest safety testing remaining. Our team has expertise in electronics, medical device fabrication, clinical brain stimulation, and technology commercialization. The work will be headquartered in Minnesota’s “Medical Alley”, an epicenter of medical device innovation. We are well-qualified to execute these Aims and bring the resulting technology to market. Success would yield a new implant optimized for network monitoring and therapy, a powerful new tool for both psychiatric treatment and cutting-edge neuroscience research.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $1,915,937 )
2024	2024	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Mental Health Research Grants	001	5	5/16/2024	NON-COMPETING CONTINUATION	$1,915,937
2024	2023	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Mental Health Research Grants	000	4	5/15/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,915,937

Issue Date FY: 2023 ( Subtotal = $1,965,523 )
2023	2023	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE # 224	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Mental Health Research Grants	000	4	6/2/2023	NON-COMPETING CONTINUATION	$1,965,523
														Subtotal = $1,965,523

Issue Date FY: 2022 ( Subtotal = $1,017,442 )
2022	2022	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE # 224	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Mental Health Research Grants	000	3	6/21/2022	NON-COMPETING CONTINUATION	$1,017,442
														Subtotal = $1,017,442

Issue Date FY: 2021 ( Subtotal = $871,272 )
2021	2021	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE # 224	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Mental Health Research Grants	000	2	6/10/2021	NON-COMPETING CONTINUATION	$871,272
														Subtotal = $871,272

Issue Date FY: 2020 ( Subtotal = $885,873 )
2020	2020	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE # 224	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Mental Health Research Grants	000	1	8/1/2020	NEW	$885,873
														Subtotal = $885,873

Grand Total All Awards = $6,656,047

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Implantable Neurostimulators for Control of Oscillatory Brain Networks

Award Number: R01MH123634

ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/01/2020

PERIOD OF PERFORMANCE END DATE: 05/31/2025

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