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From Nerve to Brain: Toward a Mechanistic Understanding of Spinal Cord Stimulation in Human Subjects

Award Number: RM1NS128741
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/22/2022
PERIOD OF PERFORMANCE END DATE: 08/31/2027

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From Nerve to Brain: Toward a Mechanistic Understanding of Spinal Cord Stimulation in Human Subjects - PROJECT SUMMARY Spinal cord stimulators (SCS) and related devices are commonly used to treat refractory pain conditions, although mechanisms underlying pain reduction remain unclear. Improved understanding of SCS and the development of biomarkers are critical for improving device design and stimulation patterns and optimizing patient selection for device treatment. The main hypothesis of this proposal is that SCS devices reduce pain by modulating the excitability of peripheral sensory nerve fibers that project within the spinal dorsal columns, and this effect can be leveraged for biomarker development. The rationale for this hypothesis is that first order low-threshold mechanoreceptors project from the periphery through the dorsal column/medial lemniscus system to the brainstem. These are the neurons that (1) have closest proximity to the epidural space, the location of stimulation, and (2) have processes in both the periphery and spinal cord tracts. We will apply specialized tests of peripheral nerve excitability, threshold tracking nerve conduction studies, to detect changes in the excitability exerted on these neurons by SCS. We will also perform secondary measurements to determine other potential mechanisms of SCS in the peripheral and central nervous systems: microneurography, to detect modulation of primary nociceptor neuron excitability; PET-MRI, to measure changes in brain neuroinflammation; plasma cytokines and chemokines, to detect systemic neuroinflammatory effects due to SCS. We will perform sensory phenotyping to identify mechanisms in specific subgroups and pain and psychometric instruments to quantify responses. Aim 1 will use a multiple crossover design in subjects who have stably implanted SCS devices, and SCS settings will be toggled between therapeutic and minimal settings. Crossover intervals will include both two-week periods and rapid two-hour periods between setting changes. Aim 2 will consist of a prospective assessment of subjects prior and after implantation of new SCS devices, with a goal of identifying predictors of pain reduction response. The successful completion of this study will yield new mechanisms by which SCS reduces pain, relevant biomarkers, and further development of promising outcomes for broad pain 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: 2026 ( Subtotal = $758,578 )
2026	2026	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Drug Use and Addiction Research Programs	000	2	2/27/2026	SUPPLEMENT FOR EXPANSION	$758,578
														Subtotal = $758,578

Issue Date FY: 2025 ( Subtotal = $3,986,147 )
2025	2025	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Drug Use and Addiction Research Programs	000	2	7/17/2025	EXTENSION WITH OR WITHOUT FUNDS	$3,986,147
														Subtotal = $3,986,147

Issue Date FY: 2022 ( Subtotal = $7,114,690 )
2022	2022	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	9/21/2022	NEW	$7,114,690
														Subtotal = $7,114,690

Grand Total All Awards = $11,859,415

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From Nerve to Brain: Toward a Mechanistic Understanding of Spinal Cord Stimulation in Human Subjects

Award Number: RM1NS128741

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/22/2022

PERIOD OF PERFORMANCE END DATE: 08/31/2027

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