NCT06968104

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

Stimulation of the Transcutaneous Auricular Vagus Nerve for Improvement of Symptoms in Patients With Post-COVID Syndrome and ME/CFS

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: University of Luxembourg · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The STIMPACT study is a single-blind, randomized, controlled crossover trial designed to evaluate the efficacy of transcutaneous auricular vagus nerve stimulation (taVNS) in alleviating fatigue and autonomic dysfunction symptoms in individuals diagnosed with Post-COVID Syndrome or Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Participants will undergo two distinct intervention phases, referred to as Intervention A and Intervention B, each lasting four weeks and separated by a washout period of at least four weeks to minimize potential carryover effects. The order of interventions will be randomized for each participant. During each intervention phase, participants will self-administer 30-minute stimulation sessions twice daily using a portable device designed for home use. Adherence to the stimulation protocol will be monitored through device usage logs and regular virtual check-ins with the research team. The primary outcome measure is the change in fatigue levels, assessed using validated instruments such as the Fatigue Severity Scale (FSS) and the Chalder Fatigue Questionnaire, alongside daily symptom tracking through electronic diaries. Secondary outcomes include assessments of quality of life (SF-36, Bell's Disability Scale), post-exertional malaise (DePaul Symptom Questionnaire - Post-Exertional Malaise subscale), autonomic function (heart rate variability metrics), sleep quality (Pittsburgh Sleep Quality Index), daytime sleepiness (Epworth Sleepiness Scale), mood (Hospital Anxiety and Depression Scale), and physical activity levels (measured via actigraphy). Data collection will occur at baseline, mid-intervention, post-intervention, and during a follow-up period, utilizing online surveys, virtual consultations, and data synchronization from wearable devices. Statistical analyses will employ mixed-model approaches to evaluate changes in outcome measures over time and between interventions, with subgroup analyses comparing responses between the Post-COVID Syndrome and ME/CFS cohorts. This study aims to provide robust evidence on the potential benefits of taVNS as a non-invasive, home-based therapeutic option for managing fatigue and autonomic dysfunction in these patient populations.

Conditions

• Post-COVID / Long-COVID
• ME/CFS

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-18
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2025-05-13
• Last updated: 2025-08-08

Locations

1 site across 1 country: Luxembourg