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

NARecruitingINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

August 1, 2022

Primary Completion Date

August 31, 2025

Study Completion Date

December 31, 2025

Conditions
Uncontrolled HypertensionHigh Blood Pressure
Interventions
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.

Trial Locations (1)

E1 1FR

RECRUITING

Barts Health NHS Trust, London

All Listed Sponsors
collaborator

Health Innovation Oxford and Thames Valley (Oxford AHSN)

UNKNOWN

lead

Queen Mary University of London

OTHER