G93.3 C83.3
Conditions
Interventions
Group 1: taVNS left ear with 25 Hz, 250 µs, 28 s on / 32 s off, intensity above the perception threshold
Group 2: taVNS left ear with 25 Hz, 250 µs, 28 s on / 32 s off, intensity below the perception
Sponsors
Knappschaft Kliniken Universitätsklinikum Bochum
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Confirmed primary CNS lymphoma (PCNSL) • Age >18 years • No depression or stable depression therapy for at least 4 weeks • Presence of clinically relevant fatigue symptoms, as assessed by the MFI-20
Exclusion criteria
Exclusion criteria: • Severe psychiatric disorders, such as schizophrenia • NGASR suicide questionnaire score >8 • Pre-existing vagus nerve stimulation or history of vagotomy • Severe cardiac conditions, such as severe arrhythmias or history of myocardial infarction • Active implants, including pacemakers, defibrillators, neurostimulators, cochlear implants, drug delivery devices, or ventricular shunts (an existing Ommaya reservoir is not an exclusion criterion) • Diagnosed neurological disorders, such as Parkinson’s syndrome, multiple sclerosis, or epilepsy • Pregnancy • Skin conditions (e.g., infection, psoriasis, or eczema) in the treatment area • Anatomical anomalies that prevent proper placement of the ear electrode • Any severe medical condition that would interfere with study participation • Lack of comprehension of the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MFI20 Score after 4 and 8 weeks Prevalence of fatigue in PCNSL-population | — |
Secondary
| Measure | Time frame |
|---|---|
| SF36, HADS, BDI2, NGASR questionnaires | — |
Countries
Germany
Contacts
Public ContactCorinna Seliger-Behme
Knappschaft Kliniken Universitätsklinikum Bochum
Outcome results
None listed