Transcutaneous Auricular Vagus Nerve Stimulation as a Treatment for Neuropathic Pain Following Spinal Cord Injury

Официальное название

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) as an Anti-inflammatory Strategy for the Treatment of Neuropathic Pain Following Spinal Cord Injury

Обзор

This pilot randomized, double-blind, sham-controlled clinical investigation will evaluate the feasibility and safety of a 30-day home-based transcutaneous auricular vagus nerve stimulation (taVNS) intervention in adults with spinal cord injury (SCI) and neuropathic pain. Participants will be randomized to receive either active taVNS targeting the auricular branch of the vagus nerve or sham taVNS delivered to the earlobe. Primary outcomes include feasibility, safety, adherence, acceptability, and blinding success. Exploratory outcomes include changes in neuropathic pain, systemic inflammatory biomarkers, vagal tone assessed via heart rate variability, and quality of life.

Подробное описание

Neuropathic pain is a common and debilitating complication following spinal cord injury (SCI) and is frequently resistant to pharmacologic treatment. Chronic neuroinflammation and reduced vagal tone are increasingly recognized contributors to persistent neuropathic pain after SCI. The vagus nerve plays a central role in immune regulation and descending pain modulation.

Transcutaneous auricular vagus nerve stimulation (taVNS) is a noninvasive neuromodulation technique that stimulates vagal afferent fibers via the external ear. Prior Health Canada-authorized trials conducted by the investigative team have demonstrated the feasibility, safety, and autonomic effects of taVNS in individuals with SCI.

This single-site, randomized, double-blind, sham-controlled pilot study will enroll 32 adults with SCI and neuropathic pain. Participants will be randomized 1:1 to receive either active or sham taVNS for 4 hours per day over a 30-day home-based intervention period. Outcomes will be assessed at baseline and immediately post-intervention. Feasibility and safety outcomes are primary, while exploratory clinical and mechanistic outcomes will inform the design of a future definitive randomized controlled trial.

Вмешательства

• Устройство Active Transcutaneous Auricular Vagus Nerve Stimulation
  Stimulation will target the auricular branch of the vagus nerve by applying stimulation to the cymba conchae region of the ear using the tVNS R device (taVNS Technologies, Erlangen, Germany). To achieve adequate stimulation while avoiding unpleasant or painful sensations, the stimulation intensity will be gradually increased in increments of 0.1mA (milliamps) until the subjective pain threshold is reached, and then reduced to a stimulus intensity just below the individuals pain threshold (expect
• Устройство Sham Transcutaneous Auricular Vagus Nerve Stimulation
  Stimulation will target the ear lobe using the tVNS R device (taVNS Technologies, Erlangen, Germany). To achieve adequate stimulation while avoiding unpleasant or painful sensations, the stimulation intensity will be gradually increased in increments of 0.1mA until the subjective pain threshold is reached, and then reduced to a stimulus intensity just below the individuals pain threshold (expected range based on prior studies 1 - 3.2mA). Pulse width will be set at 100μs and frequency will be set

Первичные конечные точки

• Recruitment Rate and Time to Recruit Target Sample Size [Срок оценки: Up to 20 months]
• Retention and Attrition During the 30-Day Intervention [Срок оценки: 30 days]
• Adherence to Daily taVNS Stimulation Prescription [Срок оценки: 30 days]
• Acceptability with the taVNS intervention [Срок оценки: Day 30]
• Incidence of Treatment-Emergent Adverse Events During Intervention [Срок оценки: 30 days]
• Success of Participant and Investigator Blinding [Срок оценки: Day 30]

Вторичные конечные точки (9)

• Change in Neuropathic Pain Assessed by the Neuropathic Pain Symptoms Inventory [Срок оценки: Baseline and Day 30]
• Change in Neuropathic Pain Assessed by the International Spinal Cord Injury Pain Basic Data Set (version 3) [Срок оценки: Baseline and Day 30]
• Change in Circulating C-Reactive Protein [Срок оценки: Baseline and Day 30]
• Change in Circulating Interleukin-1 Beta [Срок оценки: Baseline and Day 30]
• Change in Circulating Interleukin-6 [Срок оценки: Baseline and Day 30]
• Change in Circulating Interferon Gamma [Срок оценки: Baseline and Day 30]
• Change in Circulating Tumor Necrosis Factor Alpha [Срок оценки: Baseline and Day 30]
• Change in Vagal Tone Assessed by Heart Rate Variability [Срок оценки: Baseline and Day 30]
• Change in Health-Related Quality of Life [Срок оценки: Baseline and Day 30]

Критерии участия

Критерии включения

• SCI of any level or severity
• 18 years of age or older
• current neuropathic pain
• on no medications or on a stable prescribed dose (no change in prior 6-weeks) of anti-inflammatory, pain medications and/or depression medications

Критерии исключения

• Prone to autonomic dysreflexia
• presence of cardiovascular disease
• pacemaker or other implanted electrical device
• cerebral shunts
• epilepsy
• pregnant or attempting to become pregnant
• current wound/infection
• unstable dose of prescribed anti-inflammatory, depression, or pain medications within past 6-weeks.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Parkwood Institute, St Joseph's Health Care London — London

Идентификаторы

NCT: NCT07588711 · ALLISON-03-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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