Status:
RECRUITING
Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Fibromyalgia
Eligibility:
All Genders
18-80 years
Phase:
NA
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...
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 (transcu...
Eligibility Criteria
Inclusion
- Subject is 18 to 80 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
- 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.
- .
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06009159
Start Date
July 1 2024
End Date
October 31 2026
Last Update
May 6 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114