Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients

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.

Conditions

Fibromyalgia

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Study Overview

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Study Details

Study overview

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.

Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients

Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients

Condition
Fibromyalgia
Intervention / Treatment

-

Contacts and Locations

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Subject is 18 to 80 years old, including both male and female subjects.
  • 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. Subject has a pain score of 4 or above (numeric pain score: 0 - 10 from no pain to worst pain).
  • 1. Subject has current cardiac arrhythmia or had implanted cardiac pacemaker or AICD device.
  • 2. Subject has major psychiatric disorder required hospitalization in the last 3 months.
  • 3. Subject has active infection at the site of device application.
  • 4. Subject has recurrent syncope symptoms within the past three months.
  • 5. Subject is pregnant.
  • 6. Subject has had VNS treatment within the past two months.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Massachusetts General Hospital,

Study Record Dates

2026-03-31