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Toward Biomarker-Guided Fibromyalgia Treatment with Non-Invasive Vagus Nerve Stimulation

Award Number: R61AR086955
ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/07/2026
PERIOD OF PERFORMANCE END DATE: 08/31/2029

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Toward Biomarker-Guided Fibromyalgia Treatment with Non-Invasive Vagus Nerve Stimulation - Fibromyalgia (FM) is a chronic debilitating painful condition and often refractory to current treatments. Novel treatment for FM is urgently needed. While there is significant heterogeneity in FM etiologies, deranged gut microbiome homeostasis, referred to as gut dysbiosis, is strongly implicated in the FM pathogenesis and raising vagus nerve tones with vagus nerve stimulation (VNS) has been shown to restore gut microbiome homeostasis. However, few clinical studies have examined the effect of VNS on FM symptoms and no studies have investigated whether VNS may alleviate FM symptoms via regulation of gut microbiome homeostasis. The gut brush border enzyme intestinal alkaline phosphatase (IAP) is a positive regulator of gut microbiome homeostasis. In our preclinical studies, IAP deficiency induced gut dysbiosis and recapitulated FM-like pain phenotypes. In our pilot clinical studies, we found that i) a large subgroup of FM patients had a low baseline IAP level in fecal samples; ii) gut microbiome structure and composition differed between FM patients with a low vs. high baseline IAP level; and iii) after transcutaneous auricular VNS (taVNS) treatment, there was a clear trend of IAP increase in FM patients with a low baseline IAP level, along with better pain relief, as compared to FM patients with a high baseline IAP level. These findings suggest that restoring IAP-regulated gut microbiome homeostasis with taVNS might be a novel strategy for alleviating FM symptoms. In this application, we propose a randomized, sham controlled, and double blinded clinical trial of FM treatment using a non-invasive taVNS device (VagaCalm). Our primary hypothesis (Specific Aim 1) is that VNS can alleviate FM symptoms. Our secondary hypothesis (Specific Aim 2) is that FM patients with a low baseline IAP level will be more responsive to taVNS. We will recruit 105 study participants who meet the inclusion and exclusion criteria in this 3-year clinical trial. Study participants will be randomly assigned to i) taVNS and ii) sham treatment and will self-administer two 30-minute taVNS or sham treatment sessions per day, separated by 8-12 hours, for six consecutive weeks. Two datasets will be collected at the baseline (week 0) and by the end of 6-week taVNS or sham treatment: 1) Clinical Response Dataset [Widespread Pain Inventory (WPI), Fibromyalgia Impact Questionnaire (FIQR), Patient Global Impression of Change (PGIC)] and 2) IAP/Microbiome/Serum Biomarker/Quantitative Sensory Testing (QST) Dataset: i) fecal samples (IAP levels; microbiome); ii) blood samples (serum biomarker); iii) QST (pain threshold, pain tolerance, temporal pain summation). We will assess the duration of taVNS effect after 6-week treatment with week 8 & 10 phone follow-ups and perform statistical analyses to examine the primary and secondary hypotheses. We anticipate that this 3-year exploratory trial will provide pivotal proof-of-concept data on the effect of taVNS on FM symptoms and shed light on the feasibility of stratifying a subgroup of FM patients with a low baseline IAP level who may be more responsive to taVNS therapy. This novel approach could enhance the effectiveness of taVNS therapy by optimizing pre-treatment patient selection via screening baseline IAP levels.


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 = $227,800 )
2026	2026	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	1	9/4/2026	NEW	$227,800
														Subtotal = $227,800

Grand Total All Awards = $227,800

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Toward Biomarker-Guided Fibromyalgia Treatment with Non-Invasive Vagus Nerve Stimulation

Award Number: R61AR086955

ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/07/2026

PERIOD OF PERFORMANCE END DATE: 08/31/2029

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