Table 3.
Acute/short-term stimulation | Long-term stimulation |
---|---|
Device level | |
– Manufacturer/name/version/edition (if applicable) | |
– Regulatory aspects (CE certification, FDA compliance etc.) | |
Design level | |
– General study design (e.g., randomized controlled) – Between- vs. within-subject design (if applicable) – Blinding of subjects, assessors, and statisticians – Intended and actual session duration (min) – Pre-stimulation period (i.e., time before task/segment of interest) – Time of day (circadian influence) – Manipulation check (in sham-controlled designs) – Type of sham control (if applicable) |
– General study design (e.g., randomized controlled) – Between- vs. within-subject design (if applicable) – Blinding of subjects, assessors, and statisticians – Intended and actual daily dose/total duration of intervention – Time of day of stimulation (i.e., free vs. instructed) – Protocol compliance monitoring and completer definition |
Stimulation level (for active and sham stimulation, if applicable) | |
– Stimulation site (specify anatomic location and steps in preparation) (e.g., using an alcohol wipe) | |
– Electrode composition and set-up | |
– Current intensity (mA) | |
– Pulse width (μs) | |
– Frequency (Hz) | |
– Duty cycle (s) | |
– Parameter descriptions: Constant current or voltage, current or voltage intensity (mA or V), pulse width, frequency, duty cycle (ON/OFF time) | |
– Waveform descriptions: uni- or bi-directional, anode/cathode placement | |
– Pulse shape and burst/non-burst stimulation | |
– Voltage (mV) in case of voltage-controlled stimulation | |
Subject level | |
– Inclusion/exclusion criteria | |
– Mean age and age range of sample | |
– Sex distribution/ethnicity | |
– Assessment of confounding variables | |
– Prior knowledge of vagal innervation of the ear by the participant | |
Adverse events | |
– Detailed reporting on methods to assess adverse events | |
– Transparent reporting on any (serious) adverse events |