SCRATCH-HTN
Full Title: Sham controlled Randomized Control Trial evaluating the Safety, Acceptability and Efficacy of Autonomic neuromodulation using trans-cutaneous vagal sensory stimulation in uncontrolled hypertensive patients: a pilot study evaluating a novel non-invasive device-based strategy
Short Title: SCRATCH-HTN
Sponsor: Queen Mary University of London
Funder: National Institute for Health Research
Chief Investigator: Dr Ajay Gupta, Clinical Reader and Consultant, Barts Cardiovascular Clinical Trials Unit (CVCTU)
Co-Investigators: Prof Amrita Ahluwalia, Professor of Vascular Pharmacology, Dean for Research, Queen Mary University of London & Director of Barts CVCTU; Dr David Collier, Director of William Harvey Clinical Research Centre, Deputy Director, Barts CTU; Dr Manish Saxena, Deputy Director William Harvey Clinical Research Centre; Dr Mamta Bajre, Health Innovation Oxford and Thames Valley, Oxford University NHS Foundation Trust
Contact (general): help-scratchhtn@qmul.ac.uk
Contact (referrals/patient information): bartshealth.scratchhtn@nhs.net, ajay.gupta3@nhs.net
Registration: https://clinicaltrials.gov/study/NCT05179343
Study Design: Pilot randomised, sham-controlled, double-blind clinical trial
Objectives:
- To determine whether treatment with transcutaneous autonomic neuromodulation (tAN) therapy can reduce daytime systolic blood pressure (SBP) more effectively than a sham placebo therapy in individuals with uncontrolled hypertension
- To assess the safety, comfort, and usability of the tAN device
Number of Participants: 63
Devices Used: Transcutaneous autonomic neuromodulation (tAN) device for auricular vagal stimulation, Afferent Medical Solution Ltd
Study Duration: 18 months
Location: William Harvey Clinical Research Centre, Barts Health NHS Trust
Summary: High blood pressure (BP) remains the leading global risk factor for cardiovascular events and associated deaths. Despite the wide availability of antihypertensive medications, many patients fail to reach recommended BP targets, highlighting an urgent need for alternative treatment strategies.
SCRATCH-HTN is a pilot randomised, double-blind, sham-controlled clinical trial evaluating a novel non-invasive device that delivers low-level electrical stimulation to the vagal sensory nerves in the tragus (front part of the ear). This form of transcutaneous autonomic neuromodulation (tAN) is intended to correct nervous system imbalances believed to contribute to hypertension.
Participants with uncontrolled hypertension will self-administer either the active tAN therapy or a sham placebo using identical-appearing devices. The trial aims to determine the effectiveness of tAN in lowering systolic blood pressure, and to evaluate its comfort and safety in home use. The study is ethically approved (REC: 21/WS/0157) and currently recruiting participants at the William Harvey Clinical Research Centre.
Find more information, downloadable documents and videos here: https://www.qmul.ac.uk/whri/research/scratch-htn/
