RECRUITING

TVNS in Long COVID-19

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A prior open label study has shown that transcutaneous vagus nerve stimulation \[tVNS\] can improve the health of some patients with postacute sequelae of SARS-CoV-2 infection (PASC), severely affected enough to also fulfill criteria for myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS). The purpose of this study is to compare two sets of stimulus parameters to determine the one that best improves the health-related quality of life of these patients over a period of 6-weeks. Patients using their assigned device for at least 30 of the 42 possible opportunities will receive the best device for an additional 6-week period.

Official Title

Use of Transcutaneous Vagus Nerve Stimulation in Reducing the Symptoms of Long COVID Patients Who Fulfill Diagnostic Criteria for ME/CFS

Quick Facts

Study Start:2024-10
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06585254

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Must have had documented Covid infection and then fulfill 2015 case definition for ME/CFS
  2. * Chalder Fatigue Scale score of 4 or greater
  3. * SF-36 Physical Function scale score ≤70
  4. * VAS values of 3 or higher from 0 \[none\] 3 \[substantial\] to 5 \[very severe burden\] on at least two of the following symptoms - fatigue; widespread pain, brain fog, post-exertional malaise
  1. * BMI ≥30
  2. * Hospitalized for COVID-19 infection
  3. * BMI ≥30
  4. * Pregnancy

Contacts and Locations

Study Contact

Patrick Quan
CONTACT
212-844-6665
Patrick.quan@mssm.edu
Anna Norweg, PhD
CONTACT
212-844-6665
anna.norweg@mssm.edu

Principal Investigator

Benjamin H Natelson, MD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Anna Norweg, PhD
STUDY_DIRECTOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Benjamin H Natelson, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai
  • Anna Norweg, PhD, STUDY_DIRECTOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-10
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • Medically unexplained illness
  • Vagus Nerve

Additional Relevant MeSH Terms

  • Long COVID
  • Chronic Fatigue Syndrome