Status:
RECRUITING
Trial of Auricular Vagus Nerve Stimulation in Painful Covid Long
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Schwa medico (device lending)
Conditions:
COVID-19
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 uni...
Detailed Description
Covid-19 is a disease that presents in several clinical forms (severity and duration). From the end of the first epidemic wave in May 2020, the persistence of symptoms several weeks or months after th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05205577
Start Date
January 9 2023
End Date
March 1 2025
Last Update
February 22 2024
Active Locations (1)
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1
Service Centre d'Evaluation et de Traitement de la Douleur
Paris, France, 75012