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Vagus Stimulation in Female Long COVID Patients.

Sponsor
Medical University of Vienna (Other)
Overall Status
Recruiting
CT.gov ID
NCT05918965
Collaborator
(none)
45
Enrollment
1
Location
3
Arms
23.3
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: transcutaneous electrical vagal neurostimulation
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effects of Transcutaneous Electrical Neurostimulation on Female Patients With Long COVID - a Pilot Study
Actual Study Start Date :
Mar 22, 2023
Anticipated Primary Completion Date :
Mar 1, 2025
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Heart rate variability [3 times for 12 weeks]

    20-minute documentation of the heart rate variability with a 24-hour-elektrocardiography

Secondary Outcome Measures

  1. blood pressure and pulse [3 times for 12 weeks]

    via Boso Medicus plus their mutiplication for the rate-pressure-product

  2. Saliva cortisol [3 times for 12 weeks]

    in the morning until the latest 10am

  3. Questionnaire Brief Fatigue Inventory (BFI) [3 times for 12 weeks]

    Fatigue evaluation

  4. Questionnaire Short form (SF)-36 [3 times for 12 weeks]

    Health related quality of life evaluation

  5. Questionnaire Borg-Scale [3 times for 12 weeks]

    Dyspnea evaluation

  6. Questionnaire Insomnia Severity Index (ISI) [3 times for 12 weeks]

    Sleep evaluation

  7. Post-COVID-19 Functional Status scale (PCFS) [3 times for 12 weeks]

    Grade 0-4

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna Vienna Austria 1090

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Richard Crevenna, Head of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT05918965
Other Study ID Numbers:
  • 1779/2022
First Posted:
Jun 26, 2023
Last Update Posted:
Jun 26, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Richard Crevenna, Head of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna
auricular transcutaneous electrical vagal nerve stimulation
TENS
Additional relevant MeSH terms:
COVID-19
Post-Acute COVID-19 Syndrome
Nervous System Diseases
Vagus Nerve Diseases
Syndrome
Disease

Study Results

No Results Posted as of Jun 26, 2023