A small handheld device that delivers gentle electrical pulses through the ear has shown promise in treating stubborn high blood pressure, according to a new clinical trial. The study, led by researchers at Queen Mary University of London, suggests that non-invasive nerve stimulation could offer a practical home treatment for patients whose blood pressure remains elevated despite medication.
The findings come from the SCRATCH-HTN trial, published in Hypertension, a journal of the American Heart Association. While the treatment did not significantly lower blood pressure across all participants compared to a placebo device, researchers observed encouraging results in patients with more severe hypertension. The technology, known as transcutaneous autonomic neuromodulation, aims to influence the autonomic nervous system, which automatically controls heart rate and blood pressure.
SCRATCH-HTN Trial Results
The trial enrolled 63 people with uncontrolled hypertension. All participants were already taking at least one medication to lower their blood pressure, but their readings remained above recommended levels. Researchers randomly divided the participants into two groups. One received active nerve stimulation, while the other used a sham device designed to serve as a comparison.
Participants used their assigned devices for 30 minutes daily during the first two weeks. For the following 10 weeks, they reduced their sessions to once per week. The results showed that the treatment was safe and generally comfortable for participants. Most also followed the prescribed schedule, suggesting that the technology could be practical for regular use at home.
However, when researchers compared blood pressure changes across the entire study population, they found no statistically significant difference between patients receiving active stimulation and those using the sham device. Despite the lack of an overall benefit, the researchers identified a potentially important finding among participants who entered the trial with more severe hypertension.
Subgroup Analysis and Future Research
A prespecified subgroup analysis revealed a greater reduction in blood pressure among these patients when they received active nerve stimulation rather than the sham treatment. This finding raises the possibility that the technique may work better for people with particularly difficult-to-control blood pressure. However, the trial was relatively small, and the subgroup results require confirmation in larger studies before any conclusions can be drawn about its effectiveness.
Dr. Ajay Gupta, Chief Investigator and Clinical Reader at Queen Mary University of London, also a Consultant Physician at Barts Health NHS Trust, emphasized the potential of the technology. He noted that while the trial did not achieve significance across the broad unselected group, those with more severe hypertension exhibited a clear blood pressure reduction in the active group compared to sham.
High blood pressure, also known as hypertension, is a major contributor to cardiovascular disease and increases the risk of heart attacks and strokes. Although medications help many patients manage the condition, a substantial number continue to have blood pressure readings above recommended targets even while receiving treatment. This ongoing challenge has encouraged scientists to explore additional approaches that could complement existing therapies.
The experimental treatment uses a technique called transcutaneous autonomic neuromodulation, which aims to influence the autonomic nervous system. By delivering mild electrical signals to nerves in the ear, researchers hope to influence the body’s natural mechanisms for regulating blood pressure without requiring an invasive procedure. The handheld device, developed by Afferent Medical Solutions, uses two small clips positioned on the tragus, the small flap of cartilage located just in front of the ear canal.
For now, the findings represent an early step rather than proof of an effective new treatment. The researchers say larger clinical trials will be essential to confirm the encouraging results in patients with severe hypertension and identify which groups, if any, could benefit most from this approach.
Source: ScienceDaily
