Official Title
Effects of Transcutaneous Electrical Neurostimulation on Female Patients With Long COVID - a Pilot Study
Brief Summary

The aim of the present pilot study is to investigate the acceptance, feasibility andimplementation of the vagus nerv stimulation in Long COVID patients. Additionally, theeffects on parameters of the autonomic nervous system as well as on symptoms of LongCOVID will be described in a pre/post comparison.For this purpose, a total of 45 female Long COVID patients will participate in therandomized controlled pilot study. Patients will perform auricular vagus stimulationdaily for 12 weeks. The patient collective will be randomized into three groups (A: 10hertz, B: 25 hertz, C: 2 hertz=control group).If appropriate results are obtained, further adequately powered intervention studies areplanned.

Detailed Description

Patients start on day 0, when the first assessment takes place. This consists of a
medical diagnostic interview and sociodemographic, anthropometric, medical and functional
data are collected (for a detailed description, see chapter 5. Statistics). Subsequently,
the patients fill out the given questionnaires (paper/pencil version), which are then
evaluated. Subsequently, the test persons are trained by a doctor how the electrical
stimulation works with a demo device. Finally, the device is taken over by the company
Schwa-Medico. The whole first assessment lasts about 2 hours and always takes place from
8 a.m. at constant room temperature (22-23 C°).

The outcome parameters are recorded before the start of the vagus nerve stimulation (T0),
during the treatment after 4 weeks (T0+4Wo) and after a total of 12 weeks (T0+12Wo) after
the end of the therapy. Which assessments are collected at the different time points is
listed in the biometry section. The assessments are performed by physicians of the
Department of Physical Medicine, Rehabilitation and Occupational Medicine. All
assessments take place at relatively the same time, at constant room temperature (22-23
C°). The patients have to appear fasting.

T0: Medical history, examination, randomization, pre-tests, enrollment. T0+4Wo:
Intermediate examination T0+12Wo: final examination, post-tests, return of device

This pilot study investigates the acceptability, feasibility, and implementation of the
VNS measure in Long COVID patients. In addition, effects on autonomic nervous system
parameters (heart rate, blood pressure, rate pressure product, heart rate variability =
HRV, cortisol in saliva), on symptoms fatigue, dyspnea as well as health-related quality
of life (HRQOL) are described:

Time points: T0, T0+4wk, T0+12wk.

Parameters - collected at relatively the same time each day, at constant room temperature
(22-23 C°):

- Documentation of blood pressure and pulse rate: by means of Boso Medicus (Bosch +
Sohn GmbH u. Co. KG, Jungingen, Germany), calculation of the so-called "rate
pressure-product" (syst. blood pressure x heart rate)

- Heart rate variability

- Salivary cortisol

- Fatigue: Brief Fatigue Inventory (BFI)

- Health-related quality of life (HRQOL): SF-36 (short form) questionnaire instrument

- Dyspnea: Modified Borg Scale

- Sleep: Insomnia Severity Index (ISI)

Recruiting
Vagus Nerve Diseases
Long Covid
Long Covid19
Post-COVID-19 Syndrome
Post-Covid Syndrome
Post COVID-19 Condition
Post COVID Condition

Device: transcutaneous electrical vagal neurostimulation

daily for 12 weeks

Eligibility Criteria

Inclusion Criteria:

- Female patients with Long COVID (history, physical examination, findings)

- age 18-70 years

- signed informed consent

Exclusion Criteria:

- Hearing aid implants (cochlear implants)

- surgical transection of the vagus nerve

- Malignancies

- autoimmune diseases

- orthopedic diseases

- rheumatological diseases

- neurological diseases

- postoperative, fresh injuries to the ear

- febrile diseases

- inflammations

- psychiatric diseases

- pacemakers

- implanted cardioverter and defibrillators (ICDs)

- seizure disorders

- Meniere's disease

- negative experience with electrotherapy

- insufficient knowledge of the German language

Eligibility Gender
Female
Eligibility Age
Minimum: 18 Years ~ Maximum: 70 Years
Countries
Austria
Locations

Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna
Vienna, Austria

Investigator: Veronika Helbich-Poschacher, M.D.
Contact: +4314040043300
veronika.helbich-poschacher@meduniwien.ac.at

Contacts

Veronika Helbich-Poschacher, M.D.
+4314040043300
veronika.helbich-poschacher@meduniwien.ac.at

Mohammad Keilani, M.D.
+4314040043300
mohammad.keilani@meduniwien.ac.at

Richard Crevenna, M.D., Principal Investigator
PMR&O

Medical University of Vienna
NCT Number
Keywords
auricular transcutaneous electrical vagal nerve stimulation
TENS
MeSH Terms
COVID-19
Post-Acute COVID-19 Syndrome
Nervous System Diseases
Vagus Nerve Diseases
Syndrome
Disease