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Modelling and Preliminary Clinical Validation of Home-based Menstrual Neuromodulation Therapy.

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    Summary

    The Nettle™ device, using transcranial direct current stimulation (tDCS), effectively reduced menstrual pain and improved function in women with primary dysmenorrhea (PD). This non-invasive therapy shows promise for women's health.

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    Area of Science:

    • Neuromodulation
    • Medical Devices
    • Pain Management

    Background:

    • Primary dysmenorrhea (PD) causes chronic pelvic pain, significantly impacting women's quality of life.
    • Current treatments for PD may have limitations, necessitating novel therapeutic approaches.

    Purpose of the Study:

    • To model and clinically validate the Nettle™ device for at-home transcranial direct current stimulation (tDCS) in alleviating PD symptoms.
    • To investigate electric field patterns induced by Nettle™ and its immediate efficacy in reducing menstrual pain and improving functionality.

    Main Methods:

    • Finite element method (FEM) simulations using realistic head models to assess electric field distribution in pain-processing brain regions.
    • A single-centre, triple-blinded, sham-controlled study with 34 women comparing active and sham tDCS using the Nettle™ device.

    Main Results:

    • The active tDCS group showed a clinically meaningful reduction in menstrual pain symptoms.
    • Medium effect sizes were observed for pain reduction (Cohen's d=0.53) and functionality improvement (Cohen's d=0.47).
    • Nettle™'s protocol focused on the medial prefrontal cortex electric field.

    Conclusions:

    • The Nettle™ device demonstrates potential as a non-invasive, cost-efficient intervention for primary dysmenorrhea.
    • Further research with comprehensive modeling and larger trials is needed to validate Nettle™ as a neuromodulation therapy for menstrual pain.
    • This study highlights potential broader applications in women's health.