ateralization of the analgesic effect of the transcutaneous vagus nerve stimulation (t-VNS®) in huma
Not Applicable
- Conditions
- Healthy volunteers
- Registration Number
- DRKS00003383
- Lead Sponsor
- cerbomed GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
healthy volunteers
healthy in terms of medical history
written informed consent form after volunteer information
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)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method psychophysical measurement of the pressure pain threshold (PPT) at the left and right hand ipsilateral and contralateral to t-VNS<br>time of measurement: befor t-VNS (PRE), during t-VNS (PERI) und after t-VNS (POST)
- Secondary Outcome Measures
Name Time Method 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<br>measurement of blood pressure and pulse<br>time of measurement: befor t-VNS (PRE), during t-VNS (PERI) und after t-VNS (POST)<br>sensitive sensations (self-evaluation by the volunteer)<br>questionnaire for vegetative symptoms (self-evaluation by the volunteer): assessment of any vegetative changes during measurements (increase/decrease e.g. salivation, lacrimation etc.).<br>number of adverse events / incidents<br>