Effects of taVNS on Fibromyalgia Pain

Обзор

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.

Вмешательства

• Устройство Transauricular vagus nerve stimulation (taVNS)
  Transauricular vagus nerve stimulation (taVNS) is a simple technique in which small surface electrodes are placed over the skin of the ear that are thought to be innervated by the auricular branch of the vagus nerve (ABVN).

Первичные конечные точки

• pain severity using the Brief Pain Inventory (BPI pain) [Срок оценки: From Baseline to Visit 19 (at 4 weeks)]

Критерии участия

Критерии включения

• Older than 18 years old.
• 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).
• must have the ability to feel sensation by Von-Frey fiber on the forearm.
• Able to provide informed consent to participate in the study.

Критерии исключения

• 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.
• 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).
• Presence of implanted cranial electronic medical devices (e.g., cochlear implants).
• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Spaulding Hospital Cambridge — Cambridge

Публикации

• 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. PMID 36543841
• 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. PMID 37870480
• 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. PMID 36140309
• 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. PMID 35053839

Идентификаторы

NCT: NCT06193317 · 2023P003467

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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