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SoleStim Neuromodulation System, a home-use device for the treatment of dysmenorrhea

Award Number: R43HD115425
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/22/2024
PERIOD OF PERFORMANCE END DATE: 07/31/2026

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SoleStim Neuromodulation System, a home-use device for the treatment of dysmenorrhea - Abstract Pain and accompanying symptoms of primary dysmenorrhea, a condition defined by cramping-associated pain during menstruation without identifiable pelvic pathology, are a true disturbance to daily activities and quality of life. High prevalence of dysmenorrhea translates to over 855 million people suffering from this condition worldwide. Severe symptoms of dysmenorrhea force up to 33% to miss school or work, resulting in 600 million hours missed annually and an annual economic burden of over $2 billion in the U.S. Non-steroidal anti- inflammatory drugs (NSAIDs) and hormonal contraception (HC) are the first-line options for treating dysmenorrhea, but with 20-25% of people not responding to NSAIDs and many finding the side effects of NSAID and HC use to be unacceptable, the overall effectiveness of these therapies is limited. Thus, there remains an urgent unmet medical need worldwide to develop a safe, effective, and accessible therapy for dysmenorrhea. Recent clinical studies have shown that acupuncture-based nerve stimulation of a specific peripheral nerve can be effective for treating dysmenorrhea symptoms. While promising for reducing pain and distress, acupuncture’s low acceptability to patients and the need for scheduled care at the clinic prevent its potential widespread use for dysmenorrhea treatment. To build on this work and address the need for a comprehensive therapy for dysmenorrhea, TheraNova has developed the SoleStim Neuromodulation System, a portable, non-invasive ,Plantar Neuromodulation (PNM) device for non-invasive stimulation of peripheral nerves. The SoleStim Neuromodulation System consists of standard, inexpensive gel electrodes and a small, battery-powered signal generator. The goal of this proposal is to conduct a pilot clinical study to evaluate the potential of SoleStim as a treatment for dysmenorrhea. We will conduct a 16-week, sham-controlled study in 33 participants with primary dysmenorrhea. Treatment effectiveness will be evaluated via participant-reported daily pain scores and standard dysmenorrhea surveys. For the first 8 weeks (Baseline Phase), participants will self-report on dysmenorrhea symptoms to establish baseline values. Then, participants will be randomized (1:1) to the active or sham treatment and self-administer daily treatment at home for the duration of the 8-week Treatment Phase while also providing self-reports on dysmenorrhea symptoms. In this single study, we will evaluate metrics of feasibility (Specific Aim 1) and acceptability (Specific Aim 2). After demonstrating feasibility in Phase I, we will conduct a long-term pivotal clinical trial in Phase II to support FDA clearance and enable commercialization after Phase II.


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 = $0 )
2025	2024	THERANOVA LLC	255 KANSAS ST STE 300	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Child Health and Human Development Extramural Research	000	1	7/21/2025	NEW	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $343,510 )
2024	2024	THERANOVA LLC	255 KANSAS ST STE 300	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Child Health and Human Development Extramural Research	000	1	8/22/2024	NEW	$343,510
														Subtotal = $343,510

Grand Total All Awards = $343,510

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SoleStim Neuromodulation System, a home-use device for the treatment of dysmenorrhea

Award Number: R43HD115425

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/22/2024

PERIOD OF PERFORMANCE END DATE: 07/31/2026

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