NCT05179343

SCRATCH-HTN Study: Evaluating Autonomic Neuromodulation Using Trans-cutaneous Vagal Stimulation in Hypertensive Patients

Sham Controlled RCT Evaluating the Safety, Acceptability and Efficacy of Autonomic Neuromodulation Using Trans-cutaneous Vagal Stimulation in Uncontrolled Hypertensive Patients: a Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Queen Mary University of London · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot, sham-controlled, double blind, single-site device clinical trial designed to evaluate the safety, acceptability and efficacy of non-invasive autonomic neuromodulation in a cohort of 63 adult patients with uncontrolled high blood pressure.

Detailed description

SCRATCH-HTN trial is a randomised sham-controlled study designed to evaluate the safety, acceptability, and efficacy of trans-cutaneous autonomic neurostimulation (tAN) in a cohort of uncontrolled medicated hypertensive patients. SCRATCH-HTN trial is designed to test the hypothesis that tAN treatment is safe and acceptable to the patient, improves the control of blood pressure in hypertension and sense of well-being amongst those who are receiving the active treatment as compared to those on sham treatment. The study will recruit 63 patients with systemic arterial hypertension (male and female aged ≥18 years) who are receiving between one and three oral antihypertensive medications and remain hypertensive with blood pressure (BP) above target levels detailed below in the eligibility criteria. The participants will be randomly allocated to the active (tAN) or sham (sham-tAN) arms of the trial on 2:1 basis, respectively. The total treatment duration is 12 weeks. Self-administration of 30 min of tAN or sham stimulations once per day for the first two weeks, and then once every week for the rest of the trial period.

Conditions

• Uncontrolled Hypertension
• High Blood Pressure

Interventions

Type	Name	Description
DEVICE	Active AffeX-CT device	(Trans-cutaneous Autonomic Neurostimulation) tAN treatment will be administered using AffeX-CT device (a device based on a totally TENS unit). AffeX device comprises of a battery-operated control unit, two electrode pairs arranged on ear clips and connected to the control unit with electrical leads. The AffeX device generates an electrical signal that is used to stimulate the nerves that naturally control the output from the sympathetic nervous system.
DEVICE	Sham AffeX-CT device	Sham Totally TENS device. The device is identical to the active device used in the study, but its only purpose is to act as a placebo. The ear-clip electrodes have been modified so that the electric current is not transmitted to the participant.

Timeline

• Start date: 2022-08-01
• Primary completion: 2025-09-08
• Completion: 2025-09-08
• First posted: 2022-01-05
• Last updated: 2025-11-19

Locations

1 site across 1 country: United Kingdom