30
Participants
Start Date
March 22, 2022
Primary Completion Date
June 27, 2022
Study Completion Date
June 29, 2022
Transcutaneous Vagus Nerve Stimulation (t-VNS)
"Type of device and current: portable machine, low frequency current, constant current Type of wave: square biphasic pulses Pulse duration: 350 microseconds Frequency: 10 Hz Number of channels: one Location and electrodes: cymba conchae at right ear (vagus branch nerve area); a clip electrode will be applied with its cathode on anterior cymba conchae, the anode placed behind.~Amplitude: from 2 times the perception threshold (individualized) at a comfortable, non-painful amplitude, and to a maximum of 9 mA. It will be increased, if necessary, each 5 minutes in order to maintain the same level of tingling sensation On-Off times: trains of 30 s on, 5 s rump up, 1 s rump down, 24 s off Duration: 20 minutes"
Transcutaneous Sympathetic Ganglion Electrical Stimulation (t-SES)
"Type of device and current: portable machine, low frequency current, constant current Type of wave: square biphasic pulses Pulse duration: 350 microseconds Frequency: 5 Hz Number of channels: two Location and electrodes: cervicothoracic area (stellate ganglion region); first channel: new 5 cm x 5 cm self-adhesive electrodes will be applied at 1-1.5 cm both sides of the vertebral spinous processes, approximately from C7 to T4, upper cathode on the left side of C7 and lower cathode on the right side.~Amplitude: 2 mA above the muscle contraction threshold (individualized) at a comfortable, non-painful amplitude and to a maximum of 25 mA. It will be increased, if necessary, each 5 minutes in order to maintain the same level of muscle contraction On-Off times: no trains, continuously delivered Duration: 20 minutes"
Sham Transcutaneous vagus nerve stimulation (Sham t-VNS)
"Type of device and current: portable machine, low frequency current, constant current Type of wave: square biphasic pulses Pulse duration: 350 microseconds Frequency: 10 Hz Number of channels: one Location and electrodes: scapha at right ear (non vagus innervated region); a clip electrode will be applied with its cathode on anterior scapha, the anode placed behind.~Amplitude: from 2 times above the perception threshold (individualized) at a comfortable, non-painful amplitude, and to a maximum of 9 mA. It will be increased, if necessary, each 5 minutes in order to maintain the same level of tingling sensation On-Off times: trains of 30 s on, 5 s rump up, 1 s rump down, 24 s off Duration: 20 minutes"
Universidade da Coruna, A Coruña
Universidade da Coruña
OTHER