Clinical trial NCT06193317: Effects of taVNS on Fibromyalgia Pain
Official title: Effects of taVNS on Fibromyalgia Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fibromyalgia, Pain
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Transauricular vagus nerve stimulation (taVNS) is a newer delivery system, using a non-invasive stimulation device placed at the ear's concha. TaVNS is a portable, safe, and low-cost intervention, and according to some studies, taVNS may influence nociception and pain perception, which can lead to potential applications for various painful illnesses, including fibromyalgia (FM). This trial aims to investigate the clinical effects of taVNS on pain control in FM subjects.


Eligibility criteria: Inclusion Criteria:

1. Older than 18 years old.
2. Diagnosis of FM pain according to the American College of Rheumatology (ACR) 2010 criteria (existing pain for more than six months with an average of at least 3 on a 0-10 VAS scale).
3. must have the ability to feel sensation by Von-Frey fiber on the forearm.
4. Able to provide informed consent to participate in the study.

Exclusion Criteria:

1. Subjects who have unstable medical conditions (e.g., uncontrolled diabetes, uncompensated cardiac issues, heart failure, or chronic obstructive pulmonary disease) or who have functional deficits, as self-reported.
2. history of substance abuse within the past six months as self-reported (if the subject reports a history of substance abuse, we will confirm using the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria).
3. Presence of implanted cranial electronic medical devices (e.g., cochlear implants).
4. pregnancy (as the safety of taVNS in the pregnant population (and children) has not been assessed (though the risk is non-significant), we will exclude pregnant women (and children). Women of child-bearing potential will be required to take a urine pregnancy test during the screening process and every two weeks of stimulation).

Primary outcomes:
measure: pain severity using the Brief Pain Inventory (BPI pain)
timeFrame: From Baseline to Visit 19 (at 4 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Spaulding Hospital Cambridge
state: Massachusetts
Study officials:
References:
citation: Kim AY, Marduy A, de Melo PS, Gianlorenco AC, Kim CK, Choi H, Song JJ, Fregni F. Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. Sci Rep. 2022 Dec 21;12(1):22055. doi: 10.1038/s41598-022-25864-1.
citation: Parente J, Carolyna Gianlorenco A, Rebello-Sanchez I, Kim M, Mario Prati J, Kyung Kim C, Choi H, Song JJ, Fregni F. Neural, Anti-Inflammatory, and Clinical Effects of Transauricular Vagus Nerve Stimulation in Major Depressive Disorder: A Systematic Review. Int J Neuropsychopharmacol. 2024 Mar 1;27(3):pyad058. doi: 10.1093/ijnp/pyad058.
citation: Gianlorenco ACL, de Melo PS, Marduy A, Kim AY, Kim CK, Choi H, Song JJ, Fregni F. Electroencephalographic Patterns in taVNS: A Systematic Review. Biomedicines. 2022 Sep 6;10(9):2208. doi: 10.3390/biomedicines10092208.
citation: Molero-Chamizo A, Nitsche MA, Bolz A, Andujar Barroso RT, Alameda Bailen JR, Garcia Palomeque JC, Rivera-Urbina GN. Non-Invasive Transcutaneous Vagus Nerve Stimulation for the Treatment of Fibromyalgia Symptoms: A Study Protocol. Brain Sci. 2022 Jan 12;12(1):95. doi: 10.3390/brainsci12010095.