R53
Conditions
Interventions
Group 1: Verum taVNS (active stimulation) Participants receive transcutaneous auricular vagus nerve stimulation (taVNS) on the left ear (cymba conchae) using a CE-certified device (tVNS Technologies G
Sponsors
Universitätsklinikum Magdeburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: General inclusion criteria: • Sufficient knowledge of German • Capacity to give consent • Ownership and ability to use an internet-enabled smartphone to use the study app and synchronize the fitness tracker Fatigue-related inclusion criteria: • Clinically relevant and subjectively debilitating fatigue (assessed using the Fatigue Severity Scale) • Fatigue has been present for at least 3 months Diagnosis-related inclusion criteria: • MS-related fatigue: Confirmed diagnosis of multiple sclerosis • Parkinson's disease-related fatigue: Confirmed diagnosis of Parkinson's disease • Post-viral fatigue: Fatigue developed in temporal association with a documented viral infection
Exclusion criteria
Exclusion criteria: • Implanted electronic devices (cochlear implant, pacemaker, defibrillator, deep brain stimulation) • Epilepsy • Current or recent (within the last 6 months) suicidal thoughts with a plan or suicide attempt • Current or recent (within the last 2 years) addiction • Pregnancy or breastfeeding • Non-continuous medication currently or in the last 3 months • Bipolar disorder • Psychotic disorder • MS relapse in the last 3 months (in cases of underlying MS) • Clinically significant cardiac arrhythmias • Current participation in another interventional study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the change in subjectively experienced fatigue, measured using the Modified Fatigue Impact Scale (MFIS) between baseline (t0) and post-intervention (t1). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include changes in quality of life (WHOQOL-BREF), depressive symptoms (Beck Depression Inventory, BDI), daytime sleepiness (Epworth Sleepiness Scale, ESS), cognitive performance (Brief International Cognitive Assessment for Multiple Sclerosis, BICAMS-M), and changes in neurophysiological parameters, in particular excitation/inhibition measures and sensory gating (P50). In addition, the sustainability of the change four weeks after completion of the intervention (follow-up, t2) will be examined for selected secondary endpoints (questionnaires: WHOQOL-BREF, BDI, ESS). Exploratory analyses will also be conducted on wearable-based parameters such as heart rate variability and activity data (actigraphy). Possible differences between the underlying disease groups (neurological, post-infectious) will also be investigated. Finally, the user-friendliness and acceptance of the home-based taVNS application will be assessed using an evaluation questionnaire at time t1. | — |
Countries
Germany
Contacts
Public ContactMaria Kühne
Universitätsklinikum Magdeburg
Outcome results
None listed