Samphire Headband approved as hormone-free and drug-free treatment for PMDD

Press release | November 5, 2026

An independent study found greater improvement in anxiety and emotional regulation with active stimulation than with placebo after three menstrual cycles.

LONDON & SAN FRANCISCO. Samphire Neuroscience today announced that the Samphire Headband (Nettle™), its CE-marked at-home brain stimulation headband, has been approved for an expanded intended purpose in the UK and EU. The device has been approved as a PMS and period pain treatment since 2024, and can now be used to assist in the management of mood symptoms related to premenstrual dysphoric disorder (PMDD). The approved PMDD-specific clinical benefit is improvement in anxiety symptoms, measured by the GAD-7 scale.

The expanded indication follows ADAPT, an independent, controlled study led by researchers at Queen Mary University of London. Forty-two participants used Nettle™ at home for 20 minutes a day during the second half of their menstrual cycle for three cycles. Twenty-two received active stimulation and 20 used a sham device designed to feel similar. The company was not involved in the study’s results analysis and the devices were purchased for the trial to avoid biases.

By the end of the third cycle, anxiety scores had fallen by an average of 6.4 points in the active group, compared with 2.1 points in the sham group, on the 21-point GAD-7 scale (p = 0.008). Active stimulation also produced greater improvement on a measure of difficulty regulating emotions (p = 0.027). Researchers also showed that active stimulation, when compared to placebo, statistically significantly improved emotional regulation, including better access to emotion regulation strategies, better acceptance of emotional responses, better impulse control and emotional clarity.

“PMDD can fully derail half of someone’s life - emotionally, professionally, interpersonally - every month,” said Emilė Radytė, PhD, CEO and co-founder of Samphire Neuroscience. “We wanted to test a treatment people could use at home during that window that is drug- and hormone-free but still medical-grade. This study gives us an encouraging result on anxiety. The expanded indication gives us a way to make that option available while we continue to build the evidence basis across mood and pain conditions.”

PMDD can cause severe emotional and physical symptoms before a period. Existing care may include antidepressants, hormonal treatments and talking therapy. The Samphire Headband (Nettle™) delivers transcranial direct current stimulation (tDCS), a weak electrical current applied through electrodes on the scalp. ADAPT tested the device in participants who were not taking antidepressant or hormonal treatment for PMDD, so the Headband was their only therapeutic used during the study.

Investigators reported no adverse events, and the findings have been submitted for peer review to be published in 2027. Larger studies are encouraged to establish how consistently treatment helps with anxiety and what other aspects of PMDD or other overlapping conditions it would improve.

The Samphire Headband was listed among TIME’s Best Inventions 2026 in the Health & Wellness category, won MEDICA’s Innovation of the Year in 2024, and is endorsed by 750+ clinicians across the US with thousands of loving customers around the world.

About Samphire Neuroscience

Samphire Neuroscience develops brain-based technology for women. Its clinical research program examines mood and pain conditions, including but not limited to premenstrual conditions, endometriosis-related pain, migraines, long Covid and other long-term chronic conditions. The Samphire Headband (Nettle™) is a medical device for use in the UK and EU. Samphire’s separate US product, the Samphire Headband (Lutea™), uses the same technology but is a general wellness device and is not yet FDA-cleared to treat PMDD.

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Notes for editors

ADAPT is registered as ISRCTN30702519 (https://www.isrctn.com/ISRCTN30702519). The study was participant-blinded and nonrandomized. Samphire supplied the devices and stimulation protocols (and was compensated for them to avoid biases); Queen Mary University of London investigators designed, conducted and analyzed the study. The PMDD data remain under peer review but have been reviewed by EU clinical authorities.

The approved intended purpose also covers assisting in the management of pain relating to menstruation and mood symptoms relating to premenstrual syndrome. The PMDD-specific clinical benefit is improvement in anxiety symptoms measured by GAD-7.