Trial of Auricular Vagus Nerve Stimulation in Painful Covid Long

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

∙ 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

Locations
Other Locations
France
Service Centre d'Evaluation et de Traitement de la Douleur
RECRUITING
Paris
Contact Information
Primary
Stéphanie Mauboussin Carlos
stephanie.mauboussincarlos@aphp.fr
+33 1 49 28 23 06
Backup
Françoise Laroche
francoise.laroche2@aphp.fr
+33 1 49 28 23 06
Time Frame
Start Date: 2023-01-09
Estimated Completion Date: 2025-03
Participants
Target number of participants: 30
Related Therapeutic Areas
Sponsors
Collaborators: Schwa medico (device lending)
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov