The National Institute of Child Health and Human Development (NICHD) awarded Theranova LLC a $343,510 Project Grant under the Child Health and Human Development Extramural Research program (CFDA 93.865) to conduct a pilot clinical study evaluating the Solestim Neuromodulation System as a treatment for dysmenorrhea (menstrual cramps). The Solestim Neuromodulation System is a portable, non-invasive device that uses plantar neuromodulation to stimulate peripheral nerves and potentially alleviate the pain and symptoms associated with primary dysmenorrhea, a condition affecting over 855 million people worldwide.
The 16-week, sham-controlled study will be conducted in 33 participants with primary dysmenorrhea to evaluate the feasibility and acceptability of the Solestim device as a treatment. Participants will self-administer daily treatments at home and report on pain scores and dysmenorrhea symptoms. If the pilot study demonstrates feasibility, Theranova plans to conduct a larger, pivotal clinical trial to support FDA clearance and commercialization of the Solestim Neuromodulation System.
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