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Noninvasive deep brain neuromodulation for refractory fibromyalgia

Award Number: UG3AR088418
ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/22/2026
PERIOD OF PERFORMANCE END DATE: 08/31/2027

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Noninvasive deep brain neuromodulation for refractory fibromyalgia - Fibromyalgia aﬀects over 10 million people in the United States and 240 million worldwide. The condition has been diﬃcult to treat, with nearly half of the subjects resistant to current treatments. Chronic opioids are being prescribed to the patients despite their lack of eﬃcacy. Neuromodulation could provide these patients with new treatment options, but current invasive approaches have a high risk-beneﬁt ratio, and noninvasive approaches do not have the necessary selectivity and intensity in the deep brain nociceptive circuits involved in the disorder. This project is significant in that it develops a circuit-directed approach to eﬀectively and selectively modulate the involved deep brain nociceptive circuits. The applicant team has developed an ultrasonic system that modulates these circuits in a controlled and precise manner. This innovative system uniquely overcomes the key barrier that has plagued applications of ultrasound to the brain: The head. The device measures the distortions of ultrasound by the head and compensates for them, thus making the head eﬀectively acoustically transparent. The team's pilot study showed that when this function is applied, ultrasound targeting the anterior cingulate cortex (ACC) can provide rapid and sustained improvements in pain intensity associated with ﬁbromyalgia. Building on these ﬁndings, this project targets three key nodes of the pain network—the ACC, the insula, and speciﬁc thalamic nuclei—repeatedly in four consecutive stimulation sessions. We hypothesize that this comprehensive and repeated modulation will provide potent and sustained reset of the pain network and thus alleviate the patients' pain symptoms. The eﬀectiveness and safety will be rigorously evaluated in a randomized sham-controlled clinical study that recruits 180 ﬁbromyalgia patients across 3 sites. The clinical study will be conducted by a team that combines ﬁbromyalgia trial expertise and ultrasound neuromodulation expertise. The study protocol was designed by EXCITE International; the Statistical Analysis Plan by Utah Data Coordinating Center. The study was designated as Non-Signiﬁcant Risk by the FDA. The study will be executed and managed by Trial-CARE at Washington University School of Medicine. In the UG3 phase, the Trial-CARE team will complete the necessary regulatory tasks to initiate the study. In the UH3 phase, Trial-CARE will execute and monitor the study across the 3 sites. The clinical study collects standard, Common Data Elements-compliant metrics of ﬁbromyalgia and mood symptoms. We predict that repeated modulation of the three key nodes involved in ﬁbromyalgia symptoms will provide rapid and sustained improvements in pain symptoms; that the improvements will be signiﬁcantly greater following active compared to sham treatment; and that these improvements will be associated with higher quality of life and global impressions of improvement. This clinical study will provide a circuit-directed approach to modulate pain symptoms associated with refractory ﬁbromyalgia. These data will inform subsequent pivotal studies for treatments of ﬁbromyalgia and possibly also other types of pain that involve hyperactive deep brain nociceptive circuits.


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 = $212,897 )
2026	2026	WASHINGTON UNIVERSITY, THE	1 BROOKINGS DR	SAINT LOUIS	MO	63130	SAINT LOUIS	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	1	9/17/2026	NEW	$212,897
														Subtotal = $212,897

Grand Total All Awards = $212,897

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Noninvasive deep brain neuromodulation for refractory fibromyalgia

Award Number: UG3AR088418

ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/22/2026

PERIOD OF PERFORMANCE END DATE: 08/31/2027

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