Massachusetts General Hospital
Charlestown, Massachusetts, 02129-2020, United States
NCT Number: NCT04777500
In this research study we want to learn more about if transcutaneous electrical nerve stimulation (TENS), a safe electrical stimulation tool, can relieve Fibromyalgia pain. A total of 60 subjects with Fibromyalgia will be enrolled in this study at Massachusetts General Hospital, Charlestown Navy Yard campus.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Charlestown, Massachusetts, 02129-2020, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
We are investigating whether taVNS can relieve chronic pain symptoms associated with Fibromyalgia.
Time frame: Baseline, week 2 and week 4.
A change in the FIQR would indicate that participants are experiencing pain relief.
Time frame: Baseline, week 2 and week 4.
Time frame: Baseline, week 2 and week 4.
Time frame: Baseline and week 4.
Time frame: Baseline and week 4.
Time frame: Baseline and week 4.
Time frame: Baseline and week 4.
6 minutes of resting state EEG (with eyes open) (Optional). We will calculate the power of oscillations in the alpha, theta, and gamma frequencies, which will be normalized by the mean power for the global spectrum.
Time frame: Baseline and week 4
We will examine inflammatory mediators such as interleukins (ILs including IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, and IL-10), IFN-γ, and tumor necrosis factor (TNF) via multiplex immunoassays using Luminex, as well as highly sensitive C-reactive protein (hsCRP), programmed death 1 (PD-1), prostaglandin E2, and BDNF.
Contact information is provided by the study sponsor or research team.
Massachusetts General Hospital
Other
Applying Transcutaneous Auricular Vagus Nerve Stimulation to Treat Fibromyalgia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07495943
Anxiety Disorders, Behavior
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07403929
Chronic Pain, Fibromyalgia
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07382921
Fibromyalgia, Muscular Diseases
Beijing, Beijing Municipality, China
View Trial DetailsNCT07082166
Fibromyalgia, Muscular Diseases
Istanbul, Turkey (Türkiye)
View Trial Details