Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients

Mass General Brigham

Status: Enrolling

Conditions: Fibromyalgia

Treatments: Device: Transcutaneous Vagus Nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06009159

2023P001211

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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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Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Transcutaneous Vagus Nerve Stimulation(tVNS)

Experimental group

Description:

receive tVNS 30 minutes per session, twice/day for 4 weeks and maintain regular medication treatment without change.

Treatment:

Device: Transcutaneous Vagus Nerve Stimulation

Sham Control group

No Intervention group

Description:

receive sham point stimulation 30 minutes per session, twice/day for 4 weeks and maintain regular medication treatment without change.