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SCRATCH‑HTN pilot: ear‑based neuromodulation safe but misses primary endpoint; 12 mmHg signal in highest‑BP subgroup

At the American College of Cardiology 2026 meeting in New Orleans, researchers presented topline results from SCRATCH‑HTN, a phase 2a, first‑in‑person pilot of transcutaneous autonomic neuromodulation (tAN) for hypertension uncontrolled on medication. Ajay Gupta of Queen Mary University of London said the device was safe and acceptable to participants but did not produce a significant benefit versus sham across the whole cohort.

The randomized pilot enrolled 63 patients with 2:1 allocation (42 assigned to active tAN). Gupta reported no overall difference between active and sham groups but said a predefined subgroup with higher baseline systolic blood pressure had a mean reduction of about 12 mmHg on tAN.

tAN in this study delivered stimulation to the outer ear to activate sensory and cranial nerve afferents and increase vagal tone, a non‑ablative approach intended to reduce sympathetic overactivity. Gupta contrasted that mechanism with renal denervation, which physically disrupts sympathetic nerves.

Blinding was a known challenge. The team used identical devices and individualized stimulation set just below each participant's perception threshold in the sham arm so subjects were told they “may or may not feel it.” Gupta acknowledged partial success on blinding and said the sham devices did not deliver current while active devices did.

Gupta identified key limitations to address in further work: improve stimulation frequency and nerve recruitment, tighten blinding so sham‑arm patients do not change medications, and enrich future cohorts for higher baseline blood pressure and markers of sympathetic overactivity.

He suggested broader cardiovascular applications if the method can be optimized and targeted, including resistant hypertension subgroups, heart failure, and cardiorenal conditions. Gupta emphasized that larger, better‑powered trials with refined stimulation parameters and patient selection are needed to test clinical benefit.

Photo credit: img.medscapestatic.com

Tags: transcutaneous autonomic neuromodulation, resistant hypertension, sham-controlled trial, vagus nerve stimulation

Topics: Neuromodulation, Vagus nerve & taVNS, Wearable neurotech