TMS treatment for pain in chronic pancreatitis

TMS治疗慢性胰腺炎疼痛

• 批准号: 6960499
• 负责人: Steven David Freedman
• 金额: $ 17万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-08-15 至 2007-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6960499
• 关键词: analgesia; brain disorders; brain electrical activity; brain mapping; chronic disease /disorder; clinical research; clinical trials; disease /therapy duration; drug administration rate /duration; human subject; human therapy evaluation; magnetic resonance imaging; narcotics; pancreatitis; patient oriented research; questionnaires; somesthetic sensory cortex; transcranial magnetic stimulation

DESCRIPTION (provided by applicant): The purpose of this protocol is to investigate a possible novel treatment - repetitive transcranial magnetic stimulation (rTMS) - for intractable visceral pain in patients with chronic pancreatitis. This study is important as pain is a major contributor to the poor quality of life in patients with chronic pancreatitis and is often refractory to medical and surgical procedures. We hypothesize that dysfunction of brain cortical regulation of visceral sensation underlies the refractory nature of the pain in patients with chronic pancreatitis. To test this, we performed a small double-blind, sham-controlled pilot study which showed that transient suppression of Somatosensory area II (SII) activity with a single session of 1 hz rTMS applied to right SII led to a significant improvement in pain scores in 3 out of 5 subjects. This improvement lasted 3-5 days and was associated with a mean reduction of pain scores by 59% and by a marked decrease in narcotic use. Transcranial magnetic stimulation to other cortical areas and the sham control rTMS sessions failed to induce similar effects, supporting the specificity of the intervention. Based on this pilot data and the experience with other rTMS applications, we hypothesize that repeated treatment sessions to the same right SII brain region, will increase the magnitude and duration of response. We, therefore, propose a randomized, parallel-group design, doubleblind and placebo controlled clinical trial to evaluate the safety and efficacy of rTMS in the treatment of pain in patients with idiopathic chronic pancreatitis. Patients will be randomized into a sham or active rTMS group. Treatment will consist of 15 consecutive days of low-frequency rTMS applied to SII. A rater blinded to the group assignment will evaluate the patients with the following scales: Visual Analogue Scale of Pain, Beck Depression Inventory, VAS of anxiety, Clinical Global Impression, Patient Global Assessment and medication reduction. Patients will be assessed over a baseline period of 3 weeks and a follow-up period of 6 months. This study represents the first to define a potential mechanism of refractory pain in this disease - brain dysfunction of the somatosensory cortex - and provide a novel therapy.

描述（由申请人提供）：该方案的目的是研究一种可能的新型治疗方法 - 重复的经颅磁刺激（RTMS） - 用于慢性胰腺炎患者的内脏疼痛。这项研究很重要，因为疼痛是慢性胰腺炎患者生活质量差的主要因素，并且通常对医疗和手术程序难治性。我们假设内脏感觉的脑皮质调节功能障碍是慢性胰腺炎患者疼痛的难治性。为了测试这一点，我们进行了一项小的双盲，假手术的初步研究，该研究表明，对体感觉区域II（SII）活性的短暂抑制作用，单个疗程的1 Hz RTMS应用于右SII，导致5名受试者的3个受试者的疼痛评分显着改善。这种改善持续了3-5天，与疼痛评分的平均降低相关，并通过明显减少麻醉性使用。针对其他皮质区域和假控制RTMS会话的经颅磁刺激未能引起相似的影响，从而支持干预的特异性。基于此试验数据和其他RTMS应用的经验，我们假设重复治疗会议到相同的右SII脑区域，将增加响应的幅度和持续时间。因此，我们提出了一种随机的，平行组的设计，双重刀片和安慰剂对照临床试验，以评估RTMS治疗特发性慢性胰腺炎患者疼痛的安全性和功效。患者将被随机分为假或活跃的RTMS组。治疗将由连续15天的低频RTMS组成。对小组分配不知情的评估者将评估患者的以下范围：疼痛的视觉模拟量表，贝克抑郁量表，焦虑量，临床全球印象，患者全球评估和减少药物治疗。将在3周的基线期间评估患者，随访期为6个月。这项研究代表了该疾病中难治性疼痛潜在机制的第一个研究 - 体感皮质的脑功能障碍 - 并提供了一种新的疗法。