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Wearable focal vibration on mobility and pain in patients with diabetic peripheral neuropathy

Award Number: R01DK141800
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/03/2026
PERIOD OF PERFORMANCE END DATE: 08/31/2029

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Wearable focal vibration on mobility and pain in patients with diabetic peripheral neuropathy - PROJECT SUMMARY/ABSTRACT Diabetic peripheral neuropathy (DPN) is the most common complication of diabetes, affecting more than 50% of the 34 million adults in the U.S. (~1 in 10) with diabetes. People with DPN display marked reductions in functional mobility and quality of life (QOL). Preventing and treating DPN symptoms remains a daunting challenge for clinicians and diabetes researchers. Our preliminary data suggest that four weeks of wearable focal vibration (FV) therapy improves functional mobility and reduces severe pain. FV therapy may be effective due to its widespread effects on the shared neural mechanisms underlying mobility and pain in DPN. Our long-term goal is to identify effective preventive and therapeutic strategies to improve the symptoms in patients with peripheral neuropathy (PN), a highly prevalent chronic disease and a leading cause of adult disability in the U.S. This application uses an eight-week randomized clinical trial of 120 participants to compare the treatment effects of four weeks of wearable FV therapy and the persistence of the therapeutic effects at eight weeks versus control with sham vibration for mobility and pain in DPN. This research proposal aims to (1) determine if the wearable FV will improve mobility at treatment completion and four weeks after; (2) determine if the wearable FV will reduce pain at treatment completion and four weeks after; and (3) to explore pain phenotypes, moderators and mediators of FV treatment responses for DPN. Participants with DPN will be randomly assigned to Arm 1: standard care and education plus wearable FV, or Arm 2: standard care plus education plus sham FV (control). The established wearable focal vibration technology (MYOVOLT), developed by Dr. Wang (PI) and the industrial partner, involves face-to-face instruction and a prescription for an at-home vibration therapy delivered to three target muscles. Both arms involve equal time and attention to DPN education based on the American Diabetes Association's recommendation. Outcomes include patient-reported DPN symptoms, clinical pain and sensation assessments, mobility, balance, gait, toe and ankle and knee strength, pain questionnaire, quantitative sensory testing pre-intervention, post-intervention, and four weeks post-intervention, and daily physical activity, sleep, and stress monitored using a Fitbit device. This work will provide valuable insight into the effect of FV on DPN, provide variance of response for several outcome measures to conduct power analysis, endorse subgrouping to individualize the evaluation and treatment and be used to optimize FV parameters for a larger definitive clinical trial. This work is particularly important because DPN has no effective treatments and is undermanaged.


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 = $1,497,985 )
2026	2026	UNIVERSITY OF FLORIDA	1523 UNION RD RM 207	GAINESVILLE	FL	32611	ALACHUA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/3/2026	NEW	$1,497,985
														Subtotal = $1,497,985

Grand Total All Awards = $1,497,985

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Wearable focal vibration on mobility and pain in patients with diabetic peripheral neuropathy

Award Number: R01DK141800

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/03/2026

PERIOD OF PERFORMANCE END DATE: 08/31/2029

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