63
Participants
Start Date
August 1, 2022
Primary Completion Date
August 31, 2025
Study Completion Date
December 31, 2025
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.
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.
RECRUITING
Barts Health NHS Trust, London
Health Innovation Oxford and Thames Valley (Oxford AHSN)
UNKNOWN
Queen Mary University of London
OTHER