Clinical trial NCT06009159: Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients
Official title: Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibromyalgia
Keywords: Vagus nerve stimulation,
pain
fibromyalgia symptoms
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 4-week of clinical study with a total of 60 subjects, randomized into 2 groups (30 subjects in tVNS and 30 subjects in control group )
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

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Primary outcomes:
measure: A modified McGill Pain Questionnaire
timeFrame: at 0,4, weeks of the study,
Secondary outcomes:
measure: Multidimensional Fatigue Inventory
timeFrame: at 0,4,8 weeks of the study
measure: Medical Outcomes Study Sleep Scale
timeFrame: at 0,4,8 weeks of the study
measure: Revised Fibromyalgia Impact Questionnaire
timeFrame: at 0,4,8 weeks of the study
measure: Medical Outcomes Study Questionnaire Short Form 36
timeFrame: at 0, 4, 8 weeks of the study
measure: Blood inflammation marker
timeFrame: at 0, 4, 8 weeks of the study
measure: Assessment of gut microbiome changes through genomic phenotypic
timeFrame: at 0, 4, 8 weeks of the study
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.