At-Home Neuromodulation Shows Promise in Selected Patients With Hypertension

High blood pressure is a major risk factor for cardiovascular disease, including heart attack and stroke. Many patients receiving treatment for hypertension still remain above recommended blood pressure targets despite medication, highlighting the need for additional approaches that can be used safely and consistently. In response to this need, researchers have evaluated a noninvasive nerve stimulation method for patients with uncontrolled hypertension.

The clinical trial was led by researchers at Queen Mary University of London and evaluated transcutaneous autonomic neuromodulation (tAN) as a potential way to influence the autonomic nervous system. Findings from the SCRATCH-HTN trial were published in Hypertension.

The handheld device, developed by Afferent Medical Solutions, delivers gentle electrical stimulation through two clips attached to the tragus, the small piece of cartilage at the front of the ear. Patients can administer the treatment themselves at home, making the approach suitable for repeated use outside a clinical setting.

The trial enrolled 63 patients with uncontrolled hypertension who were already taking one or more blood pressure medications. Participants were randomly assigned to receive either active treatment or a sham device. They used the device for 30 minutes each day for two weeks, followed by once-weekly treatment for an additional 10 weeks.

The treatment was safe and well tolerated, with participants showing high adherence. Across the overall study population, however, there was no significant difference in blood pressure reduction between the active treatment and sham groups. A prespecified subgroup analysis found a greater reduction among participants who had more severe hypertension at the start of the trial.

The researchers said larger studies are needed to investigate these findings further. Future trials are expected to determine whether a more targeted approach can identify patients most likely to benefit and clarify whether noninvasive neuromodulation could have a role in selected patients with uncontrolled hypertension.

“This is an exciting, highly patient-acceptable technology that could ultimately provide a cheap, scalable solution for millions. Although 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,” said Dr. Ajay Gupta, chief investigator, clinical reader at Queen Mary University of London and consultant physician at Barts Health NHS Trust.

“As the first and most thorough study of its kind, this points toward important new research directions that could help us understand whether noninvasive neuromodulation can benefit particular groups of patients with uncontrolled hypertension,” added Dr. Gupta.

Related Links
Queen Mary University of London
Afferent Medical Solutions