Key result
Transcutaneous autonomic neuromodulation fails to lower overall blood pressure, but benefits patients with SBP >160.
Why the study?
Approximately 40% of hypertensive patients do not achieve recommended BP targets despite medications, and alternative device-based strategies are often expensive or invasive.
Does noninvasive transcutaneous autonomic neuromodulation reduce blood pressure in patients with uncontrolled hypertension?
RCT
Double-blind
Randomized
Does noninvasive transcutaneous autonomic neuromodulation reduce blood pressure in patients with uncontrolled hypertension?
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“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.”
Noninvasive transcutaneous autonomic neuromodulation is safe but does not significantly lower blood pressure in the general population of patients with uncontrolled hypertension.
BACKGROUND: Despite antihypertensive medications, ≈40% of patients with hypertension fail to achieve recommended blood pressure (BP) targets. Alternative device-based strategies are often expensive or invasive. We evaluated the safety, acceptability, and potential efficacy of a noninvasive transcutaneous autonomic neuromodulation (tAN) device. METHODS: SCRATCH-HTN (Sham Controlled Randomized Trial Evaluating the Safety, Acceptability and Efficacy of Autonomic Neuromodulation using Transcutaneous Vagal Sensory Stimulation in Uncontrolled Hypertensive Patients) was a double-blind, sham-controlled, phase 2a trial enrolling patients with uncontrolled hypertension (mean daytime systolic BP [SBP] ≥135 mm Hg and diastolic BP ≥85 mm Hg) on 1 or more medications. Participants self-administered active tAN or sham treatment for 30 minutes daily for 14 days, then 10 weekly sessions. Primary end points were safety and acceptability. The primary efficacy end point was change in daytime ambulatory SBP from baseline to 3 months. Secondary end points included BP, heart rate, and quality of life at 1 and 3 months. RESULTS: interaction 0.003): participants with baseline SBP >160 mm Hg showed a greater response to tAN. No significant differences were observed for other secondary end points. tAN was safe and acceptable. CONCLUSIONS: tAN is safe and well-tolerated in patients with hypertension. No significant BP-lowering effect was demonstrated, although a potential benefit in subgroups or a modest effect in a larger cohort cannot be excluded and warrants evaluation. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05179343. URL: XXX; Unique identifier: 14509154.
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Gupta et al. (2026) conducted an RCT in Uncontrolled hypertension. Noninvasive transcutaneous autonomic neuromodulation (tAN) vs. Sham treatment was evaluated on Safety and acceptability, and change in daytime ambulatory SBP from baseline to 3 months. Noninvasive transcutaneous autonomic neuromodulation was safe but showed no significant blood pressure-lowering effect overall, though patients with SBP >160 mm Hg had a greater response (P=0.003).
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