Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcutaneous Vagus Nerve Stimulation.
- Who it may be relevant to
- Registry conditions: Fibromyalgia. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
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.
Interventions
- Device Transcutaneous Vagus Nerve Stimulation
30 minutes stimulation, twice per day for 4 weeks
Primary outcome measures
- A modified McGill Pain Questionnaire [Time frame: at 0,4, weeks of the study,]
Secondary outcome measures (6)
- Multidimensional Fatigue Inventory [Time frame: at 0,4,8 weeks of the study]
- Medical Outcomes Study Sleep Scale [Time frame: at 0,4,8 weeks of the study]
- Revised Fibromyalgia Impact Questionnaire [Time frame: at 0,4,8 weeks of the study]
- Medical Outcomes Study Questionnaire Short Form 36 [Time frame: at 0, 4, 8 weeks of the study]
- Blood inflammation marker [Time frame: at 0, 4, 8 weeks of the study]
- Assessment of gut microbiome changes through genomic phenotypic [Time frame: at 0, 4, 8 weeks of the study]
Eligibility criteria
Inclusion criteria
- 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).
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.
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Massachusetts General Hospital — Boston
Publications
- Moisset X, Lanteri-Minet M, Fontaine D. Neurostimulation methods in the treatment of chronic pain. J Neural Transm (Vienna). 2020 Apr;127(4):673-686. doi: 10.1007/s00702-019-02092-y. Epub 2019 Oct 21. PMID 31637517
- Yuan H, Silberstein SD. Vagus Nerve and Vagus Nerve Stimulation, a Comprehensive Review: Part I. Headache. 2016 Jan;56(1):71-8. doi: 10.1111/head.12647. Epub 2015 Sep 14. PMID 26364692
- Maffei ME. Fibromyalgia: Recent Advances in Diagnosis, Classification, Pharmacotherapy and Alternative Remedies. Int J Mol Sci. 2020 Oct 23;21(21):7877. doi: 10.3390/ijms21217877. PMID 33114203
Identifiers
NCT: NCT06009159 · 2023P001211