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Transcutaneous Electrical Acustimulation Synchronized with Natural Breathing for Treatment of Epigastric Pain Syndrome

Award Number: K23AT014015
ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP
PERIOD OF PERFORMANCE START DATE: 07/20/2026
PERIOD OF PERFORMANCE END DATE: 06/30/2031

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Transcutaneous Electrical Acustimulation Synchronized with Natural Breathing for Treatment of Epigastric Pain Syndrome - SUMMARY Epigastric pain syndrome (EPS), a subtype of functional dyspepsia (FD), affects up to 4.5% of the US population, severely impairing quality of life and driving substantial healthcare costs. Current treatments are limited, leaving EPS-associated abdominal pain difficult to manage with fluctuating, lifelong symptoms. Notably, approximately 31.7% of FD/EPS patients use opioids - despite recommendations against their use - which worsen symptoms and increase healthcare utilization. Acupuncture-based therapies, including electroacupuncture (EA) and needleless transcutaneous electrical acustimulation (TEA), have been shown to reduce gastric pain and hypersensitivity and improve gastric motility, potentially via vagal pathway modulation. Preliminary clinical studies indicate that synchronizing TEA with respiration (STEA) enhances these benefits. We have developed a novel STEA device - AutoSTEA - that automatically detects the user’s respiratory waveform and synchronizes treatment with natural breathing. This automated approach simplifies the treatment process and may improve usability and adherence for home-based treatment. In this revised feasibility proposal, we will evaluate the safety, usability, adherence, retention, and data completeness of AutoSTEA in a randomized, sham-controlled, parallel-group trial in adults with EPS. The study is not powered to establish efficacy; rather, it will generate feasibility benchmarks and preliminary clinical and mechanistic estimates, including symptom assessments and noninvasive physiologic measures such as EGG and ECG/HRV. Pilot data from this career development award will form the foundation for a future adequately powered R01 clinical trial to assess AutoSTEA’s efficacy in a larger, diverse population.


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 = $189,000 )
2026	2026	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	The National Institute of Neurological Disorders and Stroke (NINDS) Helping to End Addiction Long-term® (HEAL) Initiative	000	1	7/22/2026	NEW	$189,000
														Subtotal = $189,000

Grand Total All Awards = $189,000

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Transcutaneous Electrical Acustimulation Synchronized with Natural Breathing for Treatment of Epigastric Pain Syndrome

Award Number: K23AT014015

ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP

PERIOD OF PERFORMANCE START DATE: 07/20/2026

PERIOD OF PERFORMANCE END DATE: 06/30/2031

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