MRI-Guided Cryoablation to Alleviate Pain in Head, Neck and Spine

Официальное название

MRI-Guided Cryoablation of Head, Neck and Spine Nerves and Facets Using the Advanced Multimodality Image Guided Operating(AMIGO) Suite

Обзор

The objective of this study is to provide pain relief to patients with facet joint disease or head and neck pain related to compression of a nerve root. The goal is to provide palliative care with superior efficacy and longer relief compared to current methods.

Подробное описание

Nerve ablation is used therapeutically to produce temporary anesthesia and diagnostically to locate the source of pain. Ablation, or purposeful destruction of tissue, relieves facet joint pain and pain related to nerve damage by disabling pain-transmitting nerves. Cryoablation for pain management is particularly useful when other modalities are too difficult to perform or have a high incidence for complications or side effects.

Currently nerve ablation is performed with bupivacaine and alcohol, but MRI-guided cryoablation of nerves and facets may result in superior efficacy and longer relief. Cryotherapy techniques provide long term analgesia and help alleviate intractable pain for patients with facet joint pain and neuralgia.

Minimally invasive Magnetic Resonance (MR)-guided ablation of nerves and facets may lead to decreased procedure time and increased relief of pain due to cancer or nerve degeneration. With the advent of the Advanced Multimodality Image Guided Operating Suite (AMIGO) at the Brigham and Women's Hospital, we have exceptional capabilities for minimally invasive image-guided procedures, including different ablation techniques. The AMIGO suite is equipped with hardware that will keep the patient stationary while the Magnetic Resonance Imaging scanner moves to the patient. Additionally, the monitoring software within the AMIGO suite allows clinicians to instantaneously analyze the imaging information which significantly reduces the risk of injury to adjacent structures.

Вмешательства

• Процедура Cryoablation under image guidance
  Observing efficacy of cryoablation to nerves and facet joints for the treatment of radicular pain and pain resulting from facet joint disease.
• Устройство MRI Seednet Cryotherapy System (Galil Medical)
  Observing efficacy of cryoablation to nerves and facet joints for the treatment of radicular pain and pain resulting from facet joint disease.

Первичные конечные точки

• Eliminating radicular pain or pain caused by spinal disease. [Срок оценки: 1 month]

Вторичные конечные точки (1)

• Long term radicular pain relief [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Participants must be willing and able to sign a written informed consent document.
• Patients must have facet joint disease or pain due to a damaged or compressed nerve that would benefit from a minimally invasive image-guided procedure (i.e., adjacent to critical structures, better visualized under 3 Tesla MRI than CT)
• Subjects must be able to adhere to the visit schedules and attend pre and post imaging.
• Participants must be at least 18 years of age
• Participants must have an estimated life expectancy of >8 weeks in the opinion of the clinician.

• Patients with radiculopathy must have the cause of pain confirmed by a nerve block within 3 months prior to ablation

Критерии исключения

• Contraindications to MRI and Gadolinium- (i.e. estimated Glomerular Filtration Rate <60ml/min, metal clips)
• Pregnant or breastfeeding woman are excluded from this research.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Brigham and Women's Hospital — Boston

Идентификаторы

NCT: NCT01788410 · 2012-P-002071

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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