Why We Run Clinical Trials
Why do we keep running clinical trials when our devices are already available? In health tech, launch isn’t the end of the science; it’s often the beginning. This piece, written by our Research and Data Manager, Ieva, explains what clinical trials actually test, why brain-based technologies like tDCS need especially rigorous evidence, and how ongoing research helps us be precise about who our products help, how, and under what conditions. It’s a look behind the scenes at how Samphire builds evidence, so we can make brain-based relief available to even more women.
“If your device is already available, why are you still running clinical trials?”
It’s a fair question, and one we hear often.
Clinical trials are one of the best tools we have to answer a bigger, more important set of questions:
Is it safe? Does it work? How well? For whom? Under what conditions?
Most of us are used to products being “done” when they launch. But health-related technology products don’t really work that way - especially when we’re talking about the brain.
This blog breaks that down.
Clinical trials: the basics
A clinical trial is a structured study in people designed to test two things:
- whether an intervention is safe and,
- whether the intervention actually produces the outcome it’s intended to produce.
Contrary to popular belief, clinical trials aren’t only for brand-new drugs. They also apply to medical devices, and to new ways of using (or combining) existing treatments.
In other words, trials are how the world shifts from “this seems promising” to “we can say this with confidence.”
On the market ≠ the science is finished
When something is available for purchase or use, it can feel like the final chapter. In research, it’s usually more like the end of the first chapter.
There are a few reasons for that:
- Real-world use is messy. People differ. Context differs. Habits differ.
- Time matters. Some effects fade, some build, while some only show up with long-term use.
- Technology evolves. The product (hardware), software, and protocols all get better, and those changes deserve to be studied, not assumed.
This is especially true for brain-based tech. The brain isn’t a simple input-output machine. Which brings us to transcranial direct current stimulation (tDCS) - the technology behind Nettle™ and Lutea™.
Why trials matter even more in brain stimulation
With brain stimulation, it’s rarely as simple as putting the same device on different people and expecting the same result.
Outcomes can shift based on a variety of factors, including:
- where someone is starting from (baseline symptoms and goals)
- sleep and stress
- medications and lifestyle
- how consistently someone follows the protocol
- whether stimulation is paired with other interventions, like training, therapy, or behavior change
And there’s another big reason trials matter: placebo effects are real - especially when you’re tracking symptoms like pain or mood, where your own expectations can shape what you feel.
That’s why strong studies often use randomized controlled designs. This study design assigns participants by chance to an active group (where they receive the intervention) or a control group (like a sham), and when possible, studies are blinded, meaning the participants themselves don’t know which group they are in, reducing the risk of their expectations influencing the results.
So why do we run trials?
At Samphire Neuroscience, generating robust evidence is the foundation of everything we build. Even though our devices are already on the market, we keep running trials because we want to be precise and honest about what our technology can (and can’t) claim.
1) We run trials to separate assumption from proof
Personal stories matter. They tell us what’s worth investigating.
But stories alone can’t tell you what reliably works, for most people, most of the time.
That’s why we run structured studies with clear outcomes, so we can measure what’s happening, not just hope it’s happening.
Our WIND study tested Nettle™ for PMS and dysmenorrhea. We tracked outcomes that users tell us mattered most: pain, mood, and functionality.
After one month of using Nettle™ in that study:
- 72% of participants reported clinically significant pain relief, with an average pain reduction of 53%
- 67% reported clinically significant improvement in low mood and functionality
Those results are encouraging. But research doesn’t stop at “encouraging.” It continues with the next questions:
How robust is this across different groups? Different settings? Longer timelines?
Check out our science page for more results, including our 6-month real-world use survey.
2) We run trials to learn what works for whom
Even when a technology like tDCS is well-tolerated, it may not help everyone equally.
Clinical trials help us understand:
- who benefits most
- who’s less likely to respond (and how we might design for them)
- who may need a different protocol, timing, or additional support
This is how care becomes more personalized, and how solutions improve over time.
3) We run trials to refine the protocol
Small differences in parameters and methodology can change outcomes and reproducibility. That’s why careful study design and standardization matter.
This is one reason we keep studying: even when a technology like tDCS is promising, the best version of the protocol often isn’t obvious at the start. It has to be tested and proven.
4) We run trials to monitor safety, and catch what’s rare
Most side effects reported with tDCS are mild and disappear quickly (things like tingling or skin redness). But systematic monitoring matters because rare risks don’t reliably show up in anecdotes.
Trials give us a structured way to track safety, spot patterns early, and improve screening and guidance as the evidence grows.
5) We run trials to make clearer, stronger claims
A claim is basically a promise: if you use this, you can expect that.
The more specific the claim, the stronger the evidence needs to be - about the outcome, the population, and the way the technology is used.
Clinical trials are how we move from cautious, general language to more precise, evidence-backed statements, without overstating what the science supports.
What we’re studying right now
You can explore completed and ongoing work on Our Studies page.
Right now, we're evaluating Nettle™'s impact in trials on PMS, PMDD, endometriosis, and chronic pelvic pain, so we can make brain-based relief available to even more women.
Want to stay in the know about our clinical trials?
If you’re interested in taking part in one of our trials, sign up for our newsletter or follow us on social media, where we announce upcoming studies first.