Vagus Nerve DiseasesVagusNCT05918965
Vagus Stimulation in Female Long COVID Patients.
A study testing transcutaneous electrical vagal neurostimulation in people with Vagus Nerve Diseases and Long COVID, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Vagus Nerve Diseases, Long COVID, Long Covid19
- What is being tested?
- transcutaneous electrical vagal neurostimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteAustria
- Study dates
- 22 Mar 2023to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients with Long COVID (history, physical examination, findings)
- age 18-70 years
- signed informed consent
Who cannot join
- Hearing aid implants (cochlear implants)
- surgical transection of the vagus nerve
- Malignancies
- autoimmune diseases
- orthopedic diseases
- rheumatological diseases
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna
Vienna, 1090
Veronika Helbich-Poschacher, M.D., +4314040043300, veronika.helbich-poschacher@meduniwien.ac.at
About this study
Official title: 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.
Read the 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)
- Conditions
- Vagus Nerve Diseases, Long COVID, Long Covid19, Post-COVID-19 Syndrome, Post-COVID Syndrome, Post COVID-19 Condition
- Being tested
- transcutaneous electrical vagal neurostimulation
- Keywords
- auricular transcutaneous electrical vagal nerve stimulation, TENS
- Medical subject headings
- Vagus Nerve Diseases, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous electrical vagal neurostimulationDevice
daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vagus Nerve Stimulation with 10 Hertz | Active comparator | 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 Receives: Device: transcutaneous electrical vagal neurostimulation |
| Vagus Nerve Stimulation with 25 Hertz | Active comparator | 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 Receives: Device: transcutaneous electrical vagal neurostimulation |
| Vagus Nerve Stimulation with 2 Hertz | Experimental | 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 Receives: Device: transcutaneous electrical vagal neurostimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
20-minute documentation of the heart rate variability with a 24-hour-elektrocardiography
Measured: 3 times for 12 weeks
Secondary outcomes (7)
blood pressure and pulse
via Boso Medicus plus their mutiplication for the rate-pressure-product
Measured: 3 times for 12 weeks
Saliva cortisol
in the morning until the latest 10am
Measured: 3 times for 12 weeks
Questionnaire Brief Fatigue Inventory (BFI)
Fatigue evaluation
Measured: 3 times for 12 weeks
Questionnaire Short form (SF)-36
Health related quality of life evaluation
Measured: 3 times for 12 weeks
Questionnaire Borg-Scale
Dyspnea evaluation
Measured: 3 times for 12 weeks
Questionnaire Insomnia Severity Index (ISI)
Sleep evaluation
Measured: 3 times for 12 weeks
Post-COVID-19 Functional Status scale (PCFS)
Grade 0-4
Measured: 3 times for 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start22 Mar 2023
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Vagus Nerve DiseasesStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Crevenna, Medical University of Vienna
- Investigators
- Richard Crevenna, M.D., Principal investigator, PMR&O
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918965
- Sponsor's protocol ID
- 1779/2022
- Acronym
- Vagus
- Status last verified
- Jun 2023
- First submitted
- 20 Jun 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Raveendran AV, Jayadevan R, Sashidharan S. Long COVID: An overview. Diabetes Metab Syndr. 2021 May-Jun;15(3):869-875. doi: 10.1016/j.dsx.2021.04.007. Epub 2021 Apr 20.
PubMed 33892403Shah W, Hillman T, Playford ED, Hishmeh L. Managing the long term effects of covid-19: summary of NICE, SIGN, and RCGP rapid guideline. BMJ. 2021 Jan 22;372:n136. doi: 10.1136/bmj.n136. No abstract available.
PubMed 33483331Sylvester SV, Rusu R, Chan B, Bellows M, O'Keefe C, Nicholson S. Sex differences in sequelae from COVID-19 infection and in long COVID syndrome: a review. Curr Med Res Opin. 2022 Aug;38(8):1391-1399. doi: 10.1080/03007995.2022.2081454. Epub 2022 Jun 20.
PubMed 35726132Dani M, Dirksen A, Taraborrelli P, Torocastro M, Panagopoulos D, Sutton R, Lim PB. Autonomic dysfunction in 'long COVID': rationale, physiology and management strategies. Clin Med (Lond). 2021 Jan;21(1):e63-e67. doi: 10.7861/clinmed.2020-0896. Epub 2020 Nov 26.
PubMed 33243837Fudim M, Qadri YJ, Ghadimi K, MacLeod DB, Molinger J, Piccini JP, Whittle J, Wischmeyer PE, Patel MR, Ulloa L. Implications for Neuromodulation Therapy to Control Inflammation and Related Organ Dysfunction in COVID-19. J Cardiovasc Transl Res. 2020 Dec;13(6):894-899. doi: 10.1007/s12265-020-10031-6. Epub 2020 May 26.
PubMed 32458400
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Electrical Neurostimulation on Female Patients With Long COVID - a Pilot Study
- ClinicalTrials.gov ID
- NCT05918965
- Acronym / sponsor ID
- Vagus / 1779/2022
- Conditions
- Vagus Nerve Diseases, Long COVID, Long Covid19, Post-COVID-19 Syndrome, Post-COVID Syndrome, Post COVID-19 Condition
- Keywords
- auricular transcutaneous electrical vagal nerve stimulation, TENS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vagus Nerve Stimulation with 10 Hertz | Active comparator | Device: transcutaneous electrical vagal neurostimulationTwelve 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 |
| Vagus Nerve Stimulation with 25 Hertz | Active comparator | Device: transcutaneous electrical vagal neurostimulationTwelve 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 |
| Vagus Nerve Stimulation with 2 Hertz | Experimental | Device: transcutaneous electrical vagal neurostimulationTwelve 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients with Long COVID (history, physical examination, findings)
- age 18-70 years
- signed informed consent
Key exclusion criteria (17 listed)
- Hearing aid implants (cochlear implants)
- surgical transection of the vagus nerve
- Malignancies
- autoimmune diseases
- orthopedic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcutaneous electrical vagal neurostimulationdaily for 12 weeks | Device | Vagus Nerve Stimulation with 10 Hertz, Vagus Nerve Stimulation with 2 Hertz, Vagus Nerve Stimulation with 25 Hertz |
Primary outcome
Heart rate variability
Time frame: 3 times for 12 weeks
20-minute documentation of the heart rate variability with a 24-hour-elektrocardiography
7 secondary outcomes
blood pressure and pulse
Time frame: 3 times for 12 weeks
Saliva cortisol
Time frame: 3 times for 12 weeks
Questionnaire Brief Fatigue Inventory (BFI)
Time frame: 3 times for 12 weeks
Questionnaire Short form (SF)-36
Time frame: 3 times for 12 weeks
Questionnaire Borg-Scale
Time frame: 3 times for 12 weeks
Questionnaire Insomnia Severity Index (ISI)
Time frame: 3 times for 12 weeks
Post-COVID-19 Functional Status scale (PCFS)
Time frame: 3 times for 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Background: PubMed 33892403Raveendran AV, Jayadevan R, Sashidharan S. Long COVID: An overview. Diabetes Metab Syndr. 2021 May-Jun;15(3):869-875. doi: 10.1016/j.dsx.2021.04.007. Epub 2021 Apr 20.
- Background: PubMed 33483331Shah W, Hillman T, Playford ED, Hishmeh L. Managing the long term effects of covid-19: summary of NICE, SIGN, and RCGP rapid guideline. BMJ. 2021 Jan 22;372:n136. doi: 10.1136/bmj.n136. No abstract available.
- Background: PubMed 35726132Sylvester SV, Rusu R, Chan B, Bellows M, O'Keefe C, Nicholson S. Sex differences in sequelae from COVID-19 infection and in long COVID syndrome: a review. Curr Med Res Opin. 2022 Aug;38(8):1391-1399. doi: 10.1080/03007995.2022.2081454. Epub 2022 Jun 20.
- Background: PubMed 33243837Dani M, Dirksen A, Taraborrelli P, Torocastro M, Panagopoulos D, Sutton R, Lim PB. Autonomic dysfunction in 'long COVID': rationale, physiology and management strategies. Clin Med (Lond). 2021 Jan;21(1):e63-e67. doi: 10.7861/clinmed.2020-0896. Epub 2020 Nov 26.
- Background: PubMed 32458400Fudim M, Qadri YJ, Ghadimi K, MacLeod DB, Molinger J, Piccini JP, Whittle J, Wischmeyer PE, Patel MR, Ulloa L. Implications for Neuromodulation Therapy to Control Inflammation and Related Organ Dysfunction in COVID-19. J Cardiovasc Transl Res. 2020 Dec;13(6):894-899. doi: 10.1007/s12265-020-10031-6. Epub 2020 May 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Crevenna, M.D. principal investigator
PMR&O
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous electrical vagal neurostimulation in people with Vagus Nerve Diseases and Long COVID, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Veronika Helbich-Poschacher, M.D. (+4314040043300, veronika.helbich-poschacher@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (time frame: 3 times for 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05918965, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.