NCT05918965

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 26, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

June 26, 2023

Status Verified

June 1, 2023

Enrollment Period

1.9 years

First QC Date

June 20, 2023

Last Update Submit

June 23, 2023

Conditions

Vagus Nerve DiseasesLong COVIDLong Covid19Post-COVID-19 SyndromePost-COVID SyndromePost COVID-19 ConditionPost COVID Condition

Keywords

auricular transcutaneous electrical vagal nerve stimulationTENS

Outcome Measures

Primary Outcomes (1)

  • Heart rate variability

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

    3 times for 12 weeks

Secondary Outcomes (7)

  • blood pressure and pulse

    3 times for 12 weeks

  • Saliva cortisol

    3 times for 12 weeks

  • Questionnaire Brief Fatigue Inventory (BFI)

    3 times for 12 weeks

  • Questionnaire Short form (SF)-36

    3 times for 12 weeks

  • Questionnaire Borg-Scale

    3 times for 12 weeks

  • +2 more secondary outcomes

Study Arms (3)

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

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

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

Device: transcutaneous electrical vagal neurostimulation

Interventions

transcutaneous electrical vagal neurostimulationDEVICE

daily for 12 weeks

Vagus Nerve Stimulation with 10 HertzVagus Nerve Stimulation with 2 HertzVagus Nerve Stimulation with 25 Hertz

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMore women are affected by Long Covid, also the homogeneity is granted in a small study population.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients with Long COVID (history, physical examination, findings)
  • age 18-70 years
  • signed informed consent

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Vienna, 1090, Austria

RECRUITING

Related Publications (5)

  • 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.

    PMID: 33892403BACKGROUND

  • 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.

    PMID: 33483331BACKGROUND

  • 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.

    PMID: 35726132BACKGROUND

  • 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.

    PMID: 33243837BACKGROUND

  • 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.

    PMID: 32458400BACKGROUND

MeSH Terms

Conditions

Vagus Nerve DiseasesPost-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Cranial Nerve DiseasesNervous System DiseasesCOVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Richard Crevenna, M.D.

    PMR&O

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Veronika Helbich-Poschacher, M.D.

CONTACT

+4314040043300veronika.helbich-poschacher@meduniwien.ac.at

Mohammad Keilani, M.D.

CONTACT

+4314040043300mohammad.keilani@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Physical Medicine, Rehabilitation and Occupational Medicine

Study Record Dates

First Submitted

June 20, 2023

First Posted

June 26, 2023

Study Start

March 22, 2023

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

June 26, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)