RECRUITING

Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients

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Conditions

FibromyalgiaVagus nerve stimulation,painfibromyalgia symptoms

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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

Fibromyalgia (FM) is a syndrome with clinical symptoms involving multiple systems. The efficacy of current treatments is inadequate, and more alternative modalities are needed for the management of FM patients. The parasympathetic vagus nerve innervates and integrates sensory, motor, and autonomic systems and has been suggested to play a role in pain modulation. The role of vagus nerve stimulation (VNS) as a treatment option for FM patients is yet to be investigated. The investigators propose to examine the hypothesis that vagus nerve stimulation could improve pain and related comorbid symptoms for FM patients.

Official Title

Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients

Quick Facts

Study Start:2024-07-01
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06009159

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:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subject is 18 to 80 years old, including both male and female subjects.
  2. 2. Subject has a documented diagnosis of FM for at least three months. This requirement is to avoid the uncertainty of an unstable pain condition and to minimize the study variation.
  3. 3. Subject has a pain score of 4 or above (numeric pain score: 0 - 10 from no pain to worst pain).
  1. 1. Subject has current cardiac arrhythmia or had implanted cardiac pacemaker or AICD device.
  2. 2. Subject has major psychiatric disorder required hospitalization in the last 3 months.
  3. 3. Subject has active infection at the site of device application.
  4. 4. Subject has recurrent syncope symptoms within the past three months.
  5. 5. Subject is pregnant.
  6. 6. Subject has had VNS treatment within the past two months.

Contacts and Locations

Study Contact

Lucy Chen, M.D.
CONTACT
617-724-3466
llchen@mgh.harvard.edu
Jianren Mao, M.D.
CONTACT
617-726-2338
jmao@mgh.harvard.edu

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

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 Date2024-07-01
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2024-07-01
Study Completion Date2026-03-31

Terms related to this study

Keywords Provided by Researchers

  • Vagus nerve stimulation,
  • pain
  • fibromyalgia symptoms

Additional Relevant MeSH Terms

  • Fibromyalgia