Safety, Acceptability and Efficacy of Noninvasive Transcutaneous-Autonomic Neuromodulation in Uncontrolled Hypertension
In brief
Noninvasive nerve stimulation shows no significant blood pressure benefit in a 63-person trial
Among 63 adults with uncontrolled hypertension, daily transcutaneous nerve stimulation was safe and acceptable but did not significantly lower daytime systolic blood pressure compared with sham treatment after three months. An analysis suggested a greater response among participants whose starting systolic pressure exceeded 160 mm Hg, but that subgroup signal needs testing in a larger study.
- Journal
- Hypertension (Dallas, Tex. : 1979) (Q1)
- Published
- 28 September 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Ajay Gupta, David Collier, James Steckelmacher, Jane Field, George Collett, Olivier Zongo, et al.
- PMID
- 42802996
- DOI
- 10.1161/HYPERTENSIONAHA.126.27847
Why clinicians should know about it
- Picked for Internal Medicine (top studies of the week, 1 November 2026): Transcutaneous autonomic neuromodulation for uncontrolled hypertension
Abstract
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: Sixty-three patients (mean age 47.2 years, 71.4% male, mean daytime BP 150/95 mm Hg) were randomized 2:1 to tAN or sham. tAN did not differ significantly from sham in daytime ambulatory SBP at 3 months (between-group difference, 2.35 mm Hg [95% CI, -4.37 to 9.07]; P=0.49) or 1 month (-1.01 mm Hg [-6.87 to 4.85]; P=0.73). Pre-specified adjusted analysis identified a significant interaction between treatment and baseline SBP (P 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.
Abstract as published, via PubMed.
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