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Simplified, Scalable 24-hour adaptive deep brain stimulation for Parkinson’s disease

Award Number: UH3NS140730
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 01/15/2025
PERIOD OF PERFORMANCE END DATE: 12/31/2029

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Simplified, Scalable 24-hour adaptive deep brain stimulation for Parkinson’s disease - Parkinson’s disease (PD) affects 1% of people over 60 years old, is highly disabling and represents a large economic burden. Therapeutic options include dopaminergic replacement and conventional DBS (cDBS) for advanced disease. However, cDBS therapy is currently unresponsive to the dynamic clinical states of patients, resulting in suboptimal control of symptoms during the day. Adaptive DBS (aDBS) seeks to solve this through personalized dynamic modulation of stimulation according to neural signals. Early studies of aDBS (completed by Drs Little, Starr and other research groups) provide proof-of-principle that aDBS can improve motor symptoms and reduce side-effects. Our team has also tested fully embedded, chronic naturalistic aDBS in a randomized, blinded study to show improvements in daytime motor symptoms and quality of life compared to cDBS. Further, we have also recently validated sleep stage specific Non Rapid Eye Movement (NREM) aDBS, that increased cortical slow waves (linked to slowed disease progression). However, full leveraging of these highly promising therapies is currently limited by 1) Lack of practical (minimally invasive) methods for chronic cortical recordings. 2) Complexity of programming aDBS due to a large parameter space. 3) Fluctuations in neural signals on multiple time scales, including circadian changes and long-term non-stationarity of signals. Our long-term goal is to advance aDBS from specialist research laboratories to real-world clinics through efficient, scalable implementation with the following advances: 1) Reduce risk and complexity of chronic cortical sensing by placing cortical leads in the subgaleal space rather than inside the cranium. 2) Utilize machine learning (ML) and data-driven biomarker and optimization techniques to minimize aDBS programming complexity. 3) Optimize aDBS across the full 24hr cycle - including sleep, with methods for long-term updating of aDBS settings. The study device will be the rechargeable, sensing and aDBS enabled, newly commercially available Medtronic Percept RC DBS system; connected to subgaleal frontal cortex leads and to directional basal ganglia leads. Our UG3 stage will support regulatory approval for Percept RC subgaleal aDBS. In UH3- 1, we will implant 24 PD patients, optimize cDBS, and identify subgroups for daytime and nighttime aDBS. In UH3-2 we will obtain in-clinic and at-home daytime naturalistic neural recordings and perform a blinded evaluation of data-driven chronic aDBS versus cDBS, for treatment of daytime motor fluctuations. In UH3-3, we will obtain in-clinic (sleep lab) and at-home nighttime naturalistic recordings and perform a blinded evaluation of chronic sleep aDBS versus cDBS, to improve NREM sleep duration and increase slow wave amplitude. We anticipate that these techniques will be the basis for a simple “turnkey” aDBS controller, to enable widespread, simple, scaleable and personalized aDBS for the full 24 hr. cycle in PD, and provide a rational foundation for adaptive neuromodulation in other neurological and psychiatric diseases.


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: 2026 ( Subtotal = $2,095,406 )
2026	2026	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	5/19/2026	EXTENSION WITH OR WITHOUT FUNDS	$2,095,406
														Subtotal = $2,095,406

Grand Total All Awards = $2,095,406

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Simplified, Scalable 24-hour adaptive deep brain stimulation for Parkinson’s disease

Award Number: UH3NS140730

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 01/15/2025

PERIOD OF PERFORMANCE END DATE: 12/31/2029

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