Vagus Stimulation in Female Long COVID Patients. (Vagus)

June 23, 2023 updated by: Richard Crevenna, Medical University of Vienna

Effects of Transcutaneous Electrical Neurostimulation on Female Patients With Long COVID - a Pilot Study

The aim of the present pilot study is to investigate the acceptance, feasibility and implementation of the vagus nerv stimulation in Long COVID patients. Additionally, the effects on parameters of the autonomic nervous system as well as on symptoms of Long COVID will be described in a pre/post comparison.

For this purpose, a total of 45 female Long COVID patients will participate in the randomized controlled pilot study. Patients will perform auricular vagus stimulation daily for 12 weeks. The patient collective will be randomized into three groups (A: 10 hertz, B: 25 hertz, C: 2 hertz=control group).

If appropriate results are obtained, further adequately powered intervention studies are planned.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vagus Nerve Stimulation with 10 Hertz

Twelve weeks home therapy with transcutaneous electrical neurostimulation (TENSeco®, CE197, Schwa-Medico Gmbh), transcutaneous 2-channel nerve stimulator.

Matching ear electrode 3 DTS.

  • Stimulation frequency: 10 Hertz
  • Intensity: sensitive threshold; clearly perceptible, but pleasant
  • Form of stimulation: biphasic
  • Duration: 30 min
  • Position: left ear
  • Frequency: daily, in the evening, when all daily activities are done
Device: transcutaneous electrical vagal neurostimulation
daily for 12 weeks
Active Comparator: Vagus Nerve Stimulation with 25 Hertz

Twelve weeks home therapy with transcutaneous electrical neurostimulation (TENSeco®, CE197, Schwa-Medico Gmbh), transcutaneous 2-channel nerve stimulator.

Matching ear electrode 3 DTS.

  • Stimulation frequency: 25 Hertz
  • Intensity: sensitive threshold; clearly perceptible, but pleasant
  • Form of stimulation: biphasic
  • Duration: 30 min
  • Position: left ear
  • Frequency: daily, in the evening, when all daily activities are done
Device: transcutaneous electrical vagal neurostimulation
daily for 12 weeks
Experimental: Vagus Nerve Stimulation with 2 Hertz

Twelve weeks home therapy with transcutaneous electrical neurostimulation (TENSeco®, CE197, Schwa-Medico Gmbh), transcutaneous 2-channel nerve stimulator.

Matching ear electrode 3 DTS.

  • Stimulation frequency: 2 Hertz
  • Intensity: sensitive threshold; clearly perceptible, but pleasant
  • Form of stimulation: biphasic
  • Duration: 30 min
  • Position: left ear
  • Frequency: daily, in the evening, when all daily activities are done
Device: transcutaneous electrical vagal neurostimulation
daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate variability
Time Frame: 3 times for 12 weeks
20-minute documentation of the heart rate variability with a 24-hour-elektrocardiography
3 times for 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood pressure and pulse
Time Frame: 3 times for 12 weeks
via Boso Medicus plus their mutiplication for the rate-pressure-product
3 times for 12 weeks
Saliva cortisol
Time Frame: 3 times for 12 weeks
in the morning until the latest 10am
3 times for 12 weeks
Questionnaire Brief Fatigue Inventory (BFI)
Time Frame: 3 times for 12 weeks
Fatigue evaluation
3 times for 12 weeks
Questionnaire Short form (SF)-36
Time Frame: 3 times for 12 weeks
Health related quality of life evaluation
3 times for 12 weeks
Questionnaire Borg-Scale
Time Frame: 3 times for 12 weeks
Dyspnea evaluation
3 times for 12 weeks
Questionnaire Insomnia Severity Index (ISI)
Time Frame: 3 times for 12 weeks
Sleep evaluation
3 times for 12 weeks
Post-COVID-19 Functional Status scale (PCFS)
Time Frame: 3 times for 12 weeks
Grade 0-4
3 times for 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2023

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

June 20, 2023

First Submitted That Met QC Criteria

June 23, 2023

First Posted (Actual)

June 26, 2023

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 23, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1779/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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