Samphire Headband
FAQs for clinicians
The Samphire Headband and clinical fit
What is the Samphire Headband?
The Samphire Headband (Nettle™ in the UK and EU; Lutea™ in the US) is a wearable neurostimulation device used with the Samphire app. It delivers transcranial direct current stimulation (tDCS) in guided sessions. The app personalizes the schedule around each user’s symptoms, goals, and hormonal pattern.
In the EU, Nettle™ is a CE-marked Class IIa medical device cleared for management of premenstrual syndrome (PMS), premenstrual dysphoric disorder (PMDD), and primary dysmenorrhea (menstrual pain). Nettle™ is also a regulated medical device in the UK; clinicians should follow the current regional label. Lutea™ is offered in the US as a general wellness product and has not been FDA cleared to treat a medical condition.
Who might be a good fit?
We most often hear from users whose mood or pain changes are associated with hormonal change, including people navigating PMS, PMDD, menstrual pain, endometriosis, and perimenopause. We have seen encouraging experiences across these groups, although response varies and the strength of clinical evidence differs by condition. The user stories offer firsthand accounts; they are personal experiences, not a substitute for trial results.
How might it affect mood and pain?
The Samphire Headband is designed around two related pathways. Stimulation of the prefrontal cortex is intended to support emotional regulation. Stimulation involving the motor cortex may also influence pain processing indirectly, including through networks involving the posterior insula. These are the scientific rationale for the approach, rather than a claim that every user’s symptoms will respond through a single proven mechanism.
What does the evidence say about PMDD?
In Samphire’s controlled PMDD study, the active group had a greater reduction in anxiety symptoms than the comparison group, alongside an improvement in a measure of emotion regulation. The study did not establish a between-group improvement in depression or overall PMDD symptom severity. Its design and size mean the findings should be discussed as promising, condition-specific evidence rather than a guarantee of benefit for an individual user. Further material is available in our resources and science overview.
What does the evidence say about endometriosis-related pain?
An early randomized study of home-based stimulation for endometriosis-related chronic pelvic pain found an encouraging pain result among participants who completed the protocol. The active stimulation group also used significantly fewer painkillers. Larger studies, including a US trial, are evaluating the approach further, and there are many users who have reported benefits outside of clinical trials as well.
In the US, we currently expect the Samphire Headband to receive FDA clearance for management of endometriosis-related chronic pelvic pain in late 2027, subject to the results of the clinical program and FDA review. It is not cleared for that use today. Further material is available in our resources and science overview.
What about menstrual pain and perimenopause?
The published WIND trial found a statistically significant reduction in menstrual pain in the active-stimulation group within one month (p = 0.001), with mean pain scores falling 52.8% from baseline. The sham group also improved (24.4%), and the group-by-time difference was not statistically significant (p = 0.34). Users have also described benefits during perimenopause. Evidence for one condition should not be treated as proof of efficacy for another. We encourage clinicians to identify the symptoms a user wants to change and assess those symptoms over time. Users can also read firsthand stories, including experiences with mood, menstrual pain, endometriosis, and menopause.
Working with a clinic
How do clinicians partner with Samphire?
Our Clinical Partnership Agreement provides a straightforward way to introduce eligible users to the Samphire Headband. Rather than purchasing a device through the clinic, a user generally starts with their own Care Membership and uses the Samphire Headband at home.
The agreement gives referred users access to a 90-day returns guarantee on their initial annual Care Membership and a discount code for that initial Care Membership. The guarantee runs from the initial purchase date and does not restart on renewal. We can explain eligibility and the current offer when setting up a partnership. Contact partnerships@samphireneuro.com or schedule a clinical partnership call.
Can a clinician try the Samphire Headband before recommending it?
Yes. Practice Samphire Headbands are available for clinicians who want to experience a session and understand the setup. We can also arrange an individual demonstration or a training session for your team through partnerships@samphireneuro.com.
Is education available for our team?
Yes. We offer accredited continuing education courses on the neuroscience behind our products. The endometriosis course is currently available, with further courses in preparation. We can also arrange a live demonstration or team training tailored to your practice. Contact partnerships@samphireneuro.com.
Can we use a Samphire Headband in the clinic?
Yes, by arrangement. Several users can use one clinic Samphire Headband, but a clinic planning repeated in-clinic sessions needs a specific agreement so session limits, user management, hygiene, support, and reporting can be set up for that model of care. We can facilitate custom clinic setups and in-clinic use case by case through partnerships@samphireneuro.com.
For many practices, the simplest pathway is one supervised demonstration or session in the clinic, followed by the user starting their own Care Membership and continuing at home. We can discuss a different setup where that better serves your users.
Can I see a user’s sessions and outcomes?
The user controls whether to share their information. A user can export their own data as a PDF and share it during a consultation or upload it to a platform their clinician already uses. There is no automatic, direct syncing of a standard user account to a clinician.
Separately, we have a clinician platform available for selected individual case studies and larger hospital or clinical partnerships. Access, consent, data fields, and workflow are discussed individually. Contact partnerships@samphireneuro.com.
Use and safety
Can the Samphire Headband be used alongside medication, hormonal treatment, or psychotherapy?
Yes. The Samphire Headband is drug-free and hormone-free. It does not change medication delivery or hormone dosing, and a neurostimulation session does not prevent someone from participating in psychotherapy. Users can generally continue medication, hormonal treatment, and psychotherapy alongside it. Clinicians should still review a user’s full history and treatment plan, especially where another stimulation device is involved. Users should not change prescribed treatment solely because they start using the Samphire Headband.
Who should not use it?
Screening should follow the current instructions for use for the relevant product and region. Key reasons to avoid use or seek individual clinical review include pregnancy, a history of seizures, active suicidal thoughts, certain implanted medical devices, and structural abnormalities affecting the skull or brain. The Samphire Headband is intended for adults. Please consult the complete product instructions rather than relying on this summary as an exhaustive contraindication list.
What if a user is trying to conceive, pregnant, or breastfeeding?
There is no known fertility interaction, so a user may use the Samphire Headband while trying to conceive. There is also no known interaction with breastfeeding; postpartum users should start only after their healthcare professional has cleared them to do so. Once pregnancy is confirmed or suspected, the user should stop using the Samphire Headband, because use during pregnancy has not been adequately studied.
How often should a user run sessions?
The app fully personalizes the schedule. Depending on the user’s symptoms and goals, many users may find their best routine within roughly 10 to 30 days per month. The user should follow their in-app plan and the instructions for their product rather than assuming that more sessions are always better.
How should a clinician and user assess whether it is helping?
Agree on the symptoms that matter to the user before they begin, then review both symptom change and day-to-day function over a meaningful period. The app includes tracking tools, and users are encouraged to complete the daily questionnaires or symptom logs so that changes can be assessed against their own baseline. They can export a PDF to discuss at a consultation. A single good or bad day is less informative than a pattern across cycles or, for users who do not cycle, across several months.
What is known about longer-term use?
Transcranial electrical stimulation has been studied for more than 30 years, particularly in research on depression and chronic pain. Repeated-use studies and longer follow-up contribute to its safety evidence. The 2026 international safety consensus report reviews a large body of sessions and reports a favorable safety profile within established parameters. It also says that the safety of extended use over years still needs further study. Long experience with the technology should not be read as years of continuous-use evidence for this particular Samphire Headband.
Evidence and contact
Where can I find clinical materials?
Start with our resources, science overview, and clinician education. We can also discuss the evidence relevant to your specialty, region, and proposed use.
Can we collaborate on research or integrate a clinical research service?
Yes. For research collaboration or a clinical research service, contact research@samphireneuro.com. For a clinic partnership, a custom setup, an in-clinic Samphire Headband, demonstrations, or team training, contact partnerships@samphireneuro.com or schedule a clinical partnership call. For clinical questions, contact support@samphireneuro.com.