Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients

Fibromyalgia Clinical Trial

Official title:

Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06009159
• Other study ID #: 2023P001211
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: Lucy Chen, M.D.
• Phone: 617-724-3466
• Email: llchen[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Subject is 18 to 70 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. .

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Device:
• Transcutaneous Vagus Nerve Stimulation
30 minutes stimulation, twice per day for 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A modified McGill Pain Questionnaire	Pain intensity, 0-10 score, with 0 means no pain and 10 means worst pain	at 0,4, weeks of the study,
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Blood inflammation marker	collect blood sample for cytokines level	at 0, 4, 8 weeks of the study
Secondary	Assessment of gut microbiome changes through genomic phenotypic	collect stool sample to analyze bacterial composition and metabolomic profiles of gut microbiome	at 0, 4, 8 weeks of the study