Healthy volunteers
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: healthy volunteers healthy in terms of medical history written informed consent form after volunteer information
Exclusion criteria
Exclusion criteria: participation in a clinical trial within the last 4 weeks prior inclusion pregnant or breastfeeding women any medication (except contraceptives) anatomical and pathological abnormalities of the ears indications that the participant is expected not to comply with the clinical investigation plan (e.g. lacking willingness to cooperate)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| psychophysical measurement of the pressure pain threshold (PPT) at the left and right hand ipsilateral and contralateral to t-VNS time of measurement: befor t-VNS (PRE), during t-VNS (PERI) und after t-VNS (POST) | — |
Secondary
| Measure | Time frame |
|---|---|
| psychophysical measurement of the mechanical pain threshold (MPT) and the mechanical pain sensitivity (MPS) at the left and right hand ipsilateral and contralateral to t-VNS measurement of blood pressure and pulse time of measurement: befor t-VNS (PRE), during t-VNS (PERI) und after t-VNS (POST) sensitive sensations (self-evaluation by the volunteer) questionnaire for vegetative symptoms (self-evaluation by the volunteer): assessment of any vegetative changes during measurements (increase/decrease e.g. salivation, lacrimation etc.). number of adverse events / incidents | — |
Countries
Germany
Contacts
cerbomed GmbH