Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients
- Conditions
- Fibromyalgia
- Interventions
- Device: Transcutaneous Vagus Nerve Stimulation
- Registration Number
- NCT06009159
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Subject is 18 to 80 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).
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Subject has current cardiac arrhythmia or had implanted cardiac pacemaker or AICD device.
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Subject has major psychiatric disorder required hospitalization in the last 3 months.
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Subject has active infection at the site of device application.
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Subject has recurrent syncope symptoms within the past three months.
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Subject is pregnant.
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Subject has had VNS treatment within the past two months.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Transcutaneous Vagus Nerve Stimulation(tVNS) Transcutaneous Vagus Nerve Stimulation receive tVNS 30 minutes per session, twice/day for 4 weeks and maintain regular medication treatment without change.
- Primary Outcome Measures
Name Time Method A modified McGill Pain Questionnaire at 0,4, weeks of the study, Pain intensity, 0-10 score, with 0 means no pain and 10 means worst pain
- Secondary Outcome Measures
Name Time Method Assessment of gut microbiome changes through genomic phenotypic at 0, 4, 8 weeks of the study collect stool sample to analyze bacterial composition and metabolomic profiles of gut microbiome
Medical Outcomes Study Sleep Scale at 0,4,8 weeks of the study sleep quality, score 1-6, base on the statement, answer 1 means all of the time, answer 6 means none of the time
Medical Outcomes Study Questionnaire Short Form 36 at 0, 4, 8 weeks of the study Quality of life measure, answer in descriptive degree of impact to life from: not at all, slightly, moderately, severe, very severe.
Revised Fibromyalgia Impact Questionnaire at 0,4,8 weeks of the study Fibromyalgia impact, 0-10, answer 0 means no impact, 10 means the most impact
Multidimensional Fatigue Inventory at 0,4,8 weeks of the study Fatigue level, 1-5 score, base on the statement, answer 1 means completely true and answer 5 means no, that is not true.
Blood inflammation marker at 0, 4, 8 weeks of the study collect blood sample for cytokines level
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States