Vagus Stimulation in Female Long COVID Patients.

Long COVID Clinical Trial

— Vagus  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05918965
• Other study ID #: 1779/2022
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: June 2023
• Source: Medical University of Vienna
• Contact: Veronika Helbich-Poschacher, M.D.
• Phone: +4314040043300
• Email: veronika.helbich-poschacher[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Disease
• Long COVID
• Nervous System Diseases
• Post-COVID-19 Syndrome
• Syndrome
• Vagus Nerve Diseases

Intervention

Device:
• transcutaneous electrical vagal neurostimulation
daily for 12 weeks

Locations

Country	Name	City	State
Austria	Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (5)

Dani 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. — View Citation

Fudim 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. — View Citation

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. Erratum In: Diabetes Metab Syndr. 2022 May;16(5):102504. Diabetes Metab Syndr. 2022 Dec;16(12):102660. — View Citation

Shah 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. Erratum In: BMJ. 2022 Jan 19;376:o126. — View Citation

Sylvester 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate variability	20-minute documentation of the heart rate variability with a 24-hour-elektrocardiography	3 times for 12 weeks
Secondary	blood pressure and pulse	via Boso Medicus plus their mutiplication for the rate-pressure-product	3 times for 12 weeks
Secondary	Saliva cortisol	in the morning until the latest 10am	3 times for 12 weeks
Secondary	Questionnaire Brief Fatigue Inventory (BFI)	Fatigue evaluation	3 times for 12 weeks
Secondary	Questionnaire Short form (SF)-36	Health related quality of life evaluation	3 times for 12 weeks
Secondary	Questionnaire Borg-Scale	Dyspnea evaluation	3 times for 12 weeks
Secondary	Questionnaire Insomnia Severity Index (ISI)	Sleep evaluation	3 times for 12 weeks
Secondary	Post-COVID-19 Functional Status scale (PCFS)	Grade 0-4	3 times for 12 weeks