Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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 8-week crossover clinical study with 30 subjects (tVNS vs. control; crossover to control vs. tVNS; 4 weeks per period). 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), after first 4 weeks of tVNS treatment or control before crossover, and at the end of the entire study.

Official Title
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Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients

Conditions
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Fibromyalgia

Intervention / Treatment
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* Device: Transcutaneous Vagus Nerve Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is 18 to 70 years old, including both male and female subjects. 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. Subject has a pain score of 4 or above (numeric pain score: 0 - 10 from no pain to worst pain). Exclusion Criteria: Subject has current cardiac arrhythmia or had implanted cardiac pacemaker or AICD device. Subject has major psychiatric disorder required hospitalization in the last 3 months. Subject has active infection at the site of device application. Subject has recurrent syncope symptoms within the past three months. Subject is pregnant. Subject has had VNS treatment within the past two months. .

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 8-week crossover clinical study with 30 subjects (tVNS vs. control; crossover to control vs. tVNS; 4 weeks per period)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcutaneous Vagus Nerve Stimulation(tVNS)<br>receive tVNS 30 minutes per session, twice/day for 4 weeks | Device: Transcutaneous Vagus Nerve Stimulation<br>* 30 minutes stimulation, twice per day for 4 weeks<br>|
| No Intervention: Control group<br>receive regular medication treatment without change. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A modified McGill Pain Questionnaire | Pain intensity, 0-10 score, with 0 means no pain and 10 means worst pain | at 0,4,8 weeks of the study, | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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. | at 0,4,8 weeks of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vagus nerve stimulation,, pain, fibromyalgia symptoms