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Combination Therapy of Home-based Trans-cranial Direct Current Stimulation and Mindfulness-based Meditation for Self-management of Clinical Pain and Symptoms in Older Adults with Knee Osteoarthritis

Award Number: R01NR019051
ORGANIZATION: NATIONAL INSTITUTE OF NURSING RESEARCH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/14/2020
PERIOD OF PERFORMANCE END DATE: 11/30/2025

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Combination Therapy of Home-based Trans-cranial Direct Current Stimulation and Mindfulness-based Meditation for Self-management of Clinical Pain and Symptoms in Older Adults with Knee Osteoarthritis - ABSTRACT The long-term goal of this project is to improve clinical pain and symptoms for older adults with knee osteoarthritis (OA) using home-based nonpharmacological approaches. Knee OA is one of the most common pain conditions among people over 45 years old, and the management of OA pain is challenging because existing pharmacological approaches often produce significant adverse events, and the treatment benefits may decrease over time. Also, knee OA pain is characterized by increased pain-related brain activation, possibly explaining the limited success of existing peripherally based treatments that target the pain locally in the area of the knee. Therefore, innovative nonpharmacological interventions targeting pain-related brain function are needed. Two nonpharmacological pain treatments, transcranial direct current stimulation (tDCS) and mindfulness-based meditation (MBM), have been shown to improve pain-related brain function in older adults with knee OA. The rationale for the proposed research is that because tDCS promotes neuroplasticity, it may potentiate the effect of MBM, which also stimulates adaptive changes in the brain. However, no investigations to date have examined whether remotely supervised tDCS paired with MBM at home can enhance pain-related brain function and reduce OA-related clinical pain and symptoms. Home-based interventions are critical because older adults with knee OA have limited mobility, and recent technological advances have created the potential for home interventions with real-time monitoring through a secure videoconferencing platform. The central hypothesis is that remotely supervised tDCS paired with MBM at home will decrease clinical pain and OA-related clinical symptoms, improve physiopsychological pain processing, and increase participant satisfaction with treatment. This hypothesis will be tested by pursuing the following specific aims: determine the effects of active tDCS paired with active MBM on clinical pain and OA-related clinical symptoms (specific aim 1); determine the effects of active tDCS paired with active MBM on physiopsychological pain processing (specific aim 2); and determine the effects of active tDCS paired with active MBM on participant satisfaction with treatment (specific aim 3). The proposed study will directly investigate the effects of remotely supervised tDCS paired with MBM at home in 200 older adults with symptomatic knee OA using a double-blind, randomized, sham-controlled, phase II parallel group (1:1:1:1 for four groups defined by 2x2 factorial design) design. The proposed research is significant because it is expected to provide valuable insight into an exciting new modality of nonpharmacological pain self-management that is extremely easy, safe, and noninvasive with minimal side effects.


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: 2025 ( Subtotal = $455,389 )
2025	2025	UNIVERSITY OF ARIZONA	845 N PARK AVE RM 538	TUCSON	AZ	85721	PIMA	USA	Nursing Research	002	6	4/11/2025	NON-COMPETING CONTINUATION	$45,537
2025	2025	UNIVERSITY OF ARIZONA	845 N PARK AVE RM 538	TUCSON	AZ	85721	PIMA	USA	Nursing Research	001	6	12/4/2024	NON-COMPETING CONTINUATION	$409,852
2025	2023	UNIVERSITY OF ARIZONA	845 N PARK AVE RM 538	TUCSON	AZ	85721	PIMA	USA	Nursing Research	000	5	11/29/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
														Subtotal = $455,389

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	UNIVERSITY OF ARIZONA	845 N PARK AVE RM 538	TUCSON	AZ	85721	PIMA	USA	Nursing Research	004	5	2/7/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2024	2023	UNIVERSITY OF ARIZONA	845 N PARK AVE RM 538	TUCSON	AZ	85721	PIMA	USA	Nursing Research	003	5	12/21/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2024	2023	UNIVERSITY OF ARIZONA	845 N PARK AVE RM 538	TUCSON	AZ	85721	PIMA	USA	Nursing Research	005	5	8/30/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2024	2023	UNIVERSITY OF ARIZONA	845 N PARK AVE RM 538	TUCSON	AZ	85721	PIMA	USA	Nursing Research	002	5	12/5/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$581,406
2024	2022	FLORIDA STATE UNIVERSITY	874 TRADITIONS WAY	TALLAHASSEE	FL	32306	LEON	USA	Nursing Research	001	3	12/5/2023	SUPPLEMENT FOR EXPANSION	-$289,561
2024	2022	FLORIDA STATE UNIVERSITY	874 TRADITIONS WAY	TALLAHASSEE	FL	32306	LEON	USA	Nursing Research	000	3	12/5/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	-$291,845
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $507,892 )
2023	2023	FLORIDA STATE UNIVERSITY	874 TRADITIONS WAY	TALLAHASSEE	FL	32306	LEON	USA	Nursing Research	001	4	9/15/2023	NON-COMPETING CONTINUATION	-$476,652
2023	2023	UNIVERSITY OF ARIZONA	845 N PARK AVE RM 538	TUCSON	AZ	85721	PIMA	USA	Nursing Research	003	5	9/19/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2023	2023	FLORIDA STATE UNIVERSITY	874 TRADITIONS WAY	TALLAHASSEE	FL	32306	LEON	USA	Nursing Research	000	4	1/31/2023	NON-COMPETING CONTINUATION	$476,652
2023	2023	UNIVERSITY OF ARIZONA	845 N PARK AVE RM 538	TUCSON	AZ	85721	PIMA	USA	Nursing Research	002	5	9/15/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$507,892
														Subtotal = $507,892

Issue Date FY: 2022 ( Subtotal = $973,809 )
2022	2022	FLORIDA STATE UNIVERSITY	874 TRADITIONS WAY	TALLAHASSEE	FL	32306	LEON	USA	Nursing Research	002	3	8/29/2022	SUPPLEMENT FOR EXPANSION	$484,992
2022	2022	FLORIDA STATE UNIVERSITY	874 TRADITIONS WAY	TALLAHASSEE	FL	32306	LEON	USA	Nursing Research	001	3	5/9/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$488,817
2022	2022	FLORIDA STATE UNIVERSITY	874 TRADITIONS WAY	TALLAHASSEE	FL	32306	LEON	USA	Nursing Research	005	3	8/30/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$513,836
2022	2021	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON, THE	7000 FANNIN ST	HOUSTON	TX	77030	HARRIS	USA	Nursing Research	004	2	8/30/2022	NON-COMPETING CONTINUATION	-$485,097
2022	2021	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON, THE	7000 FANNIN ST	HOUSTON	TX	77030	HARRIS	USA	Nursing Research	000	2	5/9/2022	NON-COMPETING CONTINUATION	$0
2022	2020	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON, THE	7000 FANNIN ST	HOUSTON	TX	77030	HARRIS	USA	Nursing Research	003	1	8/30/2022	NEW	-$28,739
														Subtotal = $973,809

Issue Date FY: 2021 ( Subtotal = $485,097 )
2021	2021	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON, THE	7000 FANNIN ST	HOUSTON	TX	77030	HARRIS	USA	Nursing Research	000	2	1/21/2021	NON-COMPETING CONTINUATION	$485,097
														Subtotal = $485,097

Issue Date FY: 2020 ( Subtotal = $494,151 )
2020	2020	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON, THE	7000 FANNIN ST	HOUSTON	TX	77030	HARRIS	USA	Nursing Research	000	1	4/13/2020	NEW	$494,151
														Subtotal = $494,151

Grand Total All Awards = $2,916,338

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Combination Therapy of Home-based Trans-cranial Direct Current Stimulation and Mindfulness-based Meditation for Self-management of Clinical Pain and Symptoms in Older Adults with Knee Osteoarthritis

Award Number: R01NR019051

ORGANIZATION: NATIONAL INSTITUTE OF NURSING RESEARCH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 04/14/2020

PERIOD OF PERFORMANCE END DATE: 11/30/2025

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