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Vagus Nerve Stimulation to the Ear to Improve Symptoms in Post-COVID-19 and ME/CFS

NCT06968104 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-08-08

No results posted yet for this study

Summary

This study is testing whether a gentle electrical stimulation of a nerve in the ear, called the vagus nerve, can help reduce fatigue and improve symptoms in people with Post-COVID Syndrome or Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). The treatment, known as transcutaneous auricular vagus nerve stimulation (taVNS), is non-invasive and can be done at home using a small device.

Participants will try two different types of stimulation, called Intervention A and Intervention B, to see which may be more effective. Each intervention lasts 4 weeks and will be separated by a break of at least 4 weeks.

Participants will use the device at home twice a day for 30 minutes. Fatigue, quality of life, sleep, and daily activity will be tracked through surveys and wearable devices. All parts of the study-including check-ins and data collection-will be done remotely.

The goal is to learn whether this type of at-home nerve stimulation can safely improve symptoms in people with Post-COVID Syndrome or ME/CFS.

Conditions

  • Post-COVID / Long-COVID
  • ME/CFS

Interventions

DEVICE

transcutaneous vagus nerve stimulation

Transcutaneous auricular vagus nerve stimulation (taVNS) delivered using the CE-certified tVNS® device (tVNS Technologies GmbH). Stimulation parameters include a pulse width of 250-500 μs, frequency of 10-25 Hz, and an individually titrated intensity (typically up to 5 mA). The device operates with a 20-50% duty cycle and is used at home.

DEVICE

transcutaneous vagus nerve stimulation

Sham stimulation using the same CE-certified tVNS® device. Electrode placement is on the earlobe, which lacks vagus nerve innervation. Stimulation parameters (pulse width, frequency, intensity, duty cycle) mirror those of the active condition, with intensity adjusted to perceptual threshold to mimic the sensation of real stimulation and preserve blinding.

Sponsors & Collaborators

  • University of Luxembourg

    lead OTHER

Principal Investigators

  • André Schulz, Prof. Dr. ; Dipl. Psych. · University of Luxembourg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-18
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • Luxembourg

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06968104 on ClinicalTrials.gov