Auricular Vagus Nerve Stimulation for Pain Relief in Long COVID

Trial of Auricular Vagus Nerve Stimulation in Painful Covid Long

This study is testing if a device that stimulates a nerve in the ear can help people with long COVID feel less pain.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (other)
• Locations: 1 site (Paris)
• Trial ID: NCT05205577 on ClinicalTrials.gov

What this trial studies

This trial investigates the use of auricular transcutaneous vagus nerve stimulation (tVNS) to alleviate pain in patients suffering from long-term symptoms following COVID-19 infection. It focuses on individuals experiencing various types of pain, including nociceptive, neuropathic, and nociplastic pain, which may persist after the acute phase of the illness. The study is a prospective, non-randomized pilot feasibility trial lasting 8 weeks, utilizing a TENS device to stimulate the vagus nerve through the ear. The aim is to evaluate the effectiveness of this neuromodulation technique in reducing pain levels in affected patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 who have experienced prolonged pain following a confirmed COVID-19 infection.

Not a fit: Patients with pain not linked to COVID-19 or those with skin injuries at the stimulation site may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce chronic pain and improve the quality of life for patients suffering from long COVID.

How similar studies have performed: While the specific application of tVNS for long COVID is novel, similar neuromodulation techniques have shown promise in treating chronic pain conditions in other studies.

Eligibility criteria

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

Where this trial is running

Paris

• Service Centre d'Evaluation et de Traitement de la Douleur — Paris, France (RECRUITING)

Study contacts

• Principal investigator: Stéphanie Mauboussin Carlos — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Stéphanie Mauboussin Carlos

Conditions: COVID-19, long covid, pain, Neuromodulation