Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients
Purpose
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.
Condition
- Fibromyalgia
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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. .
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- 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
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Transcutaneous Vagus Nerve Stimulation(tVNS) |
receive tVNS 30 minutes per session, twice/day for 4 weeks and maintain regular medication treatment without change. |
|
|
No Intervention Sham Control group |
receive sham point stimulation 30 minutes per session, twice/day for 4 weeks and maintain regular medication treatment without change. |
|
Recruiting Locations
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital
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.