G93.3 F32
Conditions
Interventions
Group 1: Transcutaneous vagal nerve stimulation at the left tragus with parameter set 1
Group 2: Placebo: Transcutaneous vagal nerve stimulation at the left tragus with parameter set 2
Sponsors
Universitätsklinikum Knappschaftskrankenhaus Bochum
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) patients during or after therapy of a gastrointestinal tumor (2) prognosis >1 year (3) clinically apperent CRF on Hornheider Assessment scale (4) age >18 (5) no or stable depression for at least 4 weeks
Exclusion criteria
Exclusion criteria: (1) severe psychiatric disease (e.g. scizophrenia) (2) >8 scores on NGASR-questionnaire (3) active vagal nerve stimulation oder s.p. vagotomy (4) relevant cardiac disease (e.g. bradycardic arrhythmia, severe insufficiency, s.p. infarction) (5) active implantat, ventricular shunt (6) inability to understand study (7) progressive neurologic disease (e.g. Parkinson's, MS, epilepsia) (8) pregnancy (9) prostate-carcinoma (10) relevant dermatologic disease at the ear (11) anatomic anomalia of the ear preventing use of electrode (12) relevant other disease which prevents participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility and acceptance measured with mean stimulation time per day | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect of taVNS on Clinical CRF and Depression scores (BDI, SF36, MFI20) | — |
Countries
Germany
Contacts
Public ContactMortimer Gierthmühlen
Neurochirurgische KlinikUniversitätsklinikum Knappschaftskrankenhaus Bochum
Outcome results
None listed