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Deep Brain Stimulation of the Subgenual Cingulate Cortex for the Treatment of Medically Refractory Chronic Low Back Pain

Award Number: UH3NS113661
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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ABSTRACT (Parent Grant) Chronic low back pain (CLBP) is one of the most ubiquitous and intractable problems in medicine and a significant source of patient suffering and disability, leading to opioid misuse and addiction. Previous neuromodulatory therapies for CLBP have focused primarily on spinal etiologies and intra-spinal mechanisms of pain transmission. However, existing pharmacological and neuromodulatory therapies have not been successful in treating CLBP. Potential gaps and opportunities include: (1) a need to better understand the brain networks underlying CLBP, (2) development of DBS devices that can better target the specific brain networks underlying CLBP in a safe and clinically testable manner, and (3) identification of neuroimaging biomarkers of response to DBS for CLBP. Pain can be separated into sensory, cognitive and affect components. Growing neuroimaging evidence shows that chronic pain is associated with widespread changes in brain circuits mediating these components with particular pathological overrepresentation of the affective component. The current proposal aims to address these critical gaps and the unmet therapeutic needs of CLBP patients by using a next- generation DBS device with directional steering capability to engage networks known to mediate the affective component of CLBP. We will use the Abbott Infinity™ DBS System, which offers segmented electrodes capable of providing directional current steering technology. In addition, we will utilize patient- specific probabilistic tractography to target the subgenual cingulate cortex (SCC) in order to engage the major fiber pathways mediating the affective component of chronic pain. The SCC region demonstrates structural connectivity to downstream brain structures also known to be involved in the affective component of chronic pain, and DBS of the SCC has been previously shown to improve affect in patients with intractable depression. The objective of this application is to propose an exploratory first-in-human clinical trial of SCC DBS for the treatment of medically refractory CLBP which leverages our multidisciplinary expertise and technical skills. Specifically, we propose the following aims in order to carry out this trial: (1) Assess the preliminary efficacy of DBS of the SCC in the treatment of medically refractory CLBP; (2) Demonstrate the safety and feasibility of SCC DBS for CLBP; and (3) Develop diffusion tensor imaging (DTI)-based blueprints of response to SCC DBS for CLBP. The overall impact of this proof-of-concept pilot trial includes validation of the concept that suffering from CLBP results from pathological activity in affective brain networks, that these networks can be accurately engaged using a next-generation directional DBS device in a safe and feasible manner, and the discovery of neuroimaging biomarkers of response to SCC DBS for CLBP.


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: 2023 ( Subtotal = $1,157,841 )
2023	2023	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Drug Abuse and Addiction Research Programs	000	2	12/19/2022	SUPPLEMENT FOR EXPANSION	$148,163
2023	2023	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Drug Abuse and Addiction Research Programs	003	3	9/19/2023	SUPPLEMENT FOR EXPANSION	-$148,163
2023	2023	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Drug Abuse and Addiction Research Programs	002	3	8/18/2023	SUPPLEMENT FOR EXPANSION	$148,163
2023	2023	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	3	8/17/2023	NON-COMPETING CONTINUATION	$1,009,678
														Subtotal = $1,157,841

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2020	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	9/20/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	9/2/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $1,062,449 )
2020	2020	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90095	LOS ANGELES	USA	Drug Abuse and Addiction Research Programs	002	2	9/8/2020	SUPPLEMENT FOR EXPANSION	$148,163
2020	2020	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90095	LOS ANGELES	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	2	7/21/2020	NON-COMPETING CONTINUATION	$914,286
2020	2019	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90095	LOS ANGELES	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	3/17/2020	NEW	$0
														Subtotal = $1,062,449

Issue Date FY: 2019 ( Subtotal = $681,714 )
2019	2019	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90095	LOS ANGELES	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	9/17/2019	NEW	$681,714
														Subtotal = $681,714

Grand Total All Awards = $2,902,004

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Deep Brain Stimulation of the Subgenual Cingulate Cortex for the Treatment of Medically Refractory Chronic Low Back Pain

Award Number: UH3NS113661

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

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