Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients

Massachusetts General Hospital60 enrolled

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.

The main goal of this study is to generate preliminary data on the effect of VNS on FM symptoms. Specifically, the investigators will utilize a recently developed, non-invasive method of tVNS (transcutaneous VNS) via auricular branches of vagus nerve (ABVN). The investigators plan to conduct an 4-week clinical study with 60 subjects randomized into 2 groups(tVNS group and control group; 30 subjects in each group). The primary outcome measure will be pain intensity. The secondary outcome measures will be fatigue, sleep, and other health-related quality of life measure. These outcome measures will be made at baseline week 0 (before any intervention), and at the end of 4 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Fibromyalgia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion 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). Exclusion Criteria: 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. .

Outcomes

Primary Outcomes

A modified McGill Pain Questionnaire

Pain intensity, 0-10 score, with 0 means no pain and 10 means worst pain

Time frame: at 0,4, weeks of the study,

Secondary Outcomes

Multidimensional Fatigue Inventory

Fatigue level, 1-5 score, base on the statement, answer 1 means completely true and answer 5 means no, that is not true.

Time frame: at 0,4,8 weeks of the study

Medical Outcomes Study Sleep Scale

sleep quality, score 1-6, base on the statement, answer 1 means all of the time, answer 6 means none of the time

Time frame: at 0,4,8 weeks of the study

Revised Fibromyalgia Impact Questionnaire

Fibromyalgia impact, 0-10, answer 0 means no impact, 10 means the most impact

Time frame: at 0,4,8 weeks of the study

Medical Outcomes Study Questionnaire Short Form 36

Quality of life measure, answer in descriptive degree of impact to life from: not at all, slightly, moderately, severe, very severe.

Time frame: at 0, 4, 8 weeks of the study

Blood inflammation marker

collect blood sample for cytokines level

Time frame: at 0, 4, 8 weeks of the study

Assessment of gut microbiome changes through genomic phenotypic

collect stool sample to analyze bacterial composition and metabolomic profiles of gut microbiome

Time frame: at 0, 4, 8 weeks of the study

Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts