Back to resultsVagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients
Primary Purpose
Fibromyalgia
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transcutaneous Vagus Nerve Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring Vagus nerve stimulation,, pain, fibromyalgia symptoms
Eligibility Criteria
Inclusion Criteria: Subject is 18 to 70 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. .
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Transcutaneous Vagus Nerve Stimulation(tVNS)
Control group
Arm Description
receive tVNS 30 minutes per session, twice/day for 4 weeks
receive regular medication treatment without change.
Outcomes
Primary Outcome Measures
A modified McGill Pain Questionnaire
Pain intensity, 0-10 score, with 0 means no pain and 10 means worst pain
Secondary Outcome Measures
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.
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
Revised Fibromyalgia Impact Questionnaire
Fibromyalgia impact, 0-10, answer 0 means no impact, 10 means the most impact
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.
Full Information
NCT ID
NCT06009159
First Posted
August 18, 2023
Last Updated
August 23, 2023
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06009159
Brief Title
Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients
Official Title
Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
October 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Vagus nerve stimulation,, pain, fibromyalgia symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
8-week crossover clinical study with 30 subjects (tVNS vs. control; crossover to control vs. tVNS; 4 weeks per period)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transcutaneous Vagus Nerve Stimulation(tVNS)
Arm Type
Experimental
Arm Description
receive tVNS 30 minutes per session, twice/day for 4 weeks
Arm Title
Control group
Arm Type
No Intervention
Arm Description
receive regular medication treatment without change.
Intervention Type
Device
Intervention Name(s)
Transcutaneous Vagus Nerve Stimulation
Intervention Description
30 minutes stimulation, twice per day for 4 weeks
Primary Outcome Measure Information:
Title
A modified McGill Pain Questionnaire
Description
Pain intensity, 0-10 score, with 0 means no pain and 10 means worst pain
Time Frame
at 0,4,8 weeks of the study,
Secondary Outcome Measure Information:
Title
Multidimensional Fatigue Inventory
Description
Fatigue level, 1-5 score, base on the statement, answer 1 means completely true and answer 5 means no, that is not true.
Time Frame
at 0,4,8 weeks of the study
Title
Medical Outcomes Study Sleep Scale
Description
sleep quality, score 1-6, base on the statement, answer 1 means all of the time, answer 6 means none of the time
Time Frame
at 0,4,8 weeks of the study
Title
Revised Fibromyalgia Impact Questionnaire
Description
Fibromyalgia impact, 0-10, answer 0 means no impact, 10 means the most impact
Time Frame
at 0,4,8 weeks of the study
Title
Medical Outcomes Study Questionnaire Short Form 36
Description
Quality of life measure, answer in descriptive degree of impact to life from: not at all, slightly, moderately, severe, very severe.
Time Frame
at 0,4,8 weeks of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is 18 to 70 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.
.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucy Chen, M.D.
Phone
617-724-3466
Email
llchen@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jianren Mao, M.D.
Phone
617-726-2338
Email
jmao@mgh.harvard.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients
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