Skip to content

Trial of Auricular Vagus Nerve Stimulation in Painful Covid Long

Unknown statusNot applicableNCT05205577
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

Patients infected with Covid 19 suffer from frequent pain (headache, migraines, joint pain, muscle pain) in the acute phase which may persist after a stay in intensive care or in an intensive care unit, in the event of post-traumatic stress syndrome, pre-existing comorbidities. The pain mechanisms observed during the covid epidemic are nociceptive / inflammatory pain, neuropathic pain, and nociplastic pain. Auricular transcutaneous vagus nerve stimulation (tVNS) is a promising therapeutic strategy that may reduce inflammation and pain level. Colosat is a prospective non-randomized pilot feasibility study. Colosat is a 8 weeks non randomized trial investigating the painful Covid long. tVNS will be performed using a transcutaneous lectrical nerve stimulation (TENS) device connected to an auricular electrode stimulating the cutaneous area of the left ear innervated by the auricular ascendant branch of the vagus nerve.

Study details

Official title
Trial of Auricular Vagus Nerve Stimulation in Painful Covid Long
Conditions
  • Covid-19
Interventions
  • Device: Tens Eco Plus
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Schwa medico (device lending)
Start date
2023-01-09
Primary completion
2025-03
Sex
All
Age range
from 18 Years to 80 Years
Results posted
No results posted in this snapshot
Countries
France
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: Subjects aged 18 to 80 with prolonged post-Covid-19 pain defined by 3 criteria according to the Haute Autorité de Santé : * Symptomatic initial episode of Covid-19 is confirmed by at least one criterion among: PCR SARS-CoV-2 +, antigenic test SARS-CoV-2 +, Serology SARS-CoV-2 +, prolonged anosmia / ageusia of sudden onset , chest scanner * Presence of at least one of the initial symptoms, beyond 4 weeks following the onset of the acute phase of the disease * Initial and prolonged symptoms not explained by another diagnosis with no known link to Covid-19 * With intact and uninjured skin at the level of the cymba concha of the left ear * Signature of informed consent * Pain of intensity\> or equal to 40 mm / 100mmm on the Visual Analogue Scale (VAS) over the last 7 days before inclusion, analgesic treatment stable for at least 2 weeks * Must be able to comply with protocol requirements * Beneficiary of a social security scheme or entitled Exclusion Criteria: * Having a hearing aid device with a left cochlear implant * Having a major hearing loss * Having an unsuitable ear canal * Use of other electrically active medical devices (TENS for chronic pain, pacemaker) * Taking treatment with strong opioids, corticosteroids or nonsteroidal anti-inflammatory drugs systemically (oral, subcutaneous, intravenous, intramuscular, transdermal). * With cognitive disorders that do not allow answering questionnaires and /or setting up the device * Known history of cardiac arrhythmias, atrioventricular block\> 1st degree, conduction disorders * Symptomatic orthostatic hypotension or history of recurrent vagal syncope * History of vagotomy * severe asthma * Pregnant, breastfeeding or having a desire to become pregnant

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05205577