NCT05205577

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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Jan 2023

Longer than P75 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 25, 2022

Completed
12 months until next milestone

Study Start

First participant enrolled

January 9, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

2.1 years

First QC Date

January 24, 2022

Last Update Submit

February 21, 2024

Conditions

COVID-19

Keywords

long covidpainNeuromodulation

Outcome Measures

Primary Outcomes (1)

  • Pain

    Difference D0-M2 of self-reported pain post Covid-19 (COVID Long) measured in a 100 mm on a Visual Analog Scale (VAS). The patient assesses the pain of the last eight days before the visit.

    2 months

Secondary Outcomes (4)

  • Analgesics

    2 months

  • PGIC

    2 months

  • Quality of life

    1 and 2 months

  • Side effects

    1 and 2 months

Interventions

Tens Eco PlusDEVICE

30min/day of stimulation at 25Hz frequency, 100 microsc pulse with intensity escalation up to 25 mA max

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Must be able to comply with protocol requirements
  • Beneficiary of a social security scheme or entitled

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service Centre d'Evaluation et de Traitement de la Douleur

Paris, 75012, France

RECRUITING

MeSH Terms

Conditions

COVID-19Post-Acute COVID-19 SyndromePain

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Stéphanie Mauboussin Carlos

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphanie Mauboussin Carlos

CONTACT

+33 1 49 28 23 06stephanie.mauboussincarlos@aphp.fr

Françoise Laroche

CONTACT

+33 1 49 28 23 06francoise.laroche2@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2022

First Posted

January 25, 2022

Study Start

January 9, 2023

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

February 22, 2024

Record last verified: 2024-02

Locations

FR(1)