Status:
ACTIVE_NOT_RECRUITING
Vagus Nerve Stimulation to the Ear to Improve Symptoms in Post-COVID-19 and ME/CFS
Lead Sponsor:
University of Luxembourg
Conditions:
Post-COVID / Long-COVID
ME/CFS
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 ...
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 au...
Eligibility Criteria
Inclusion
- Diagnosis of Post-COVID Syndrome (persistent symptoms \> 3 months post-infection)
- Diagnosis of ME/CFS (following Canadian Consensus Criteria) Aged 18-65
- Moderate to severe fatigue (Fatigue Severity Scale ≥ 5)
- Stable medical regimen for at least 3 months
- Participants who are willing to follow the treatment protocol, and able to comply with remote monitoring.
- Sufficient proficiency in German or English language
Exclusion
- Pacemaker or other implanted electronic or metallic devices
- Neurological or psychiatric disorders unrelated to ME/CFS or Post-COVID Syndrome
- Pregnancy or breastfeeding
- History of vagus nerve damage or significant ear injury
- Previous or ongoing use of taVNS
- Bradycardia (resting heart rate below 60 beats per minute)
- permanent jewelry at close proximity to the ear tragus;
- Known severe coronary disease or recent heart attack (within 5 years)
- Medications that may influence autonomic function, HRV, and fatigue
Key Trial Info
Start Date :
July 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06968104
Start Date
July 18 2025
End Date
October 1 2026
Last Update
August 8 2025
Active Locations (1)
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1
University of Luxembourg
Esch-sur-Alzette, Luxembourg, L-4366