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）：本方案的目的是研究一种可能的新型治疗方法——重复经颅磁刺激（rTMS）——治疗慢性胰腺炎患者的顽固性内脏疼痛。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原因，并且通常难以通过内科和外科手术治疗。我们假设大脑皮层内脏感觉调节功能障碍是慢性胰腺炎患者难治性疼痛的根源。为了测试这一点，我们进行了一项小型双盲、假对照试点研究，结果表明，对右侧 SII 施加单次 1 hz rTMS 短暂抑制体感 II 区 (SII) 活动，可显着改善疼痛评分在五分之三的科目中。这种改善持续了 3-5 天，疼痛评分平均降低了 59%，麻醉剂使用量显着减少。对其他皮质区域的经颅磁刺激和假对照 rTMS 治疗未能引起类似的效果，支持了干预的特异性。根据该试点数据和其他 rTMS 应用的经验，我们假设对同一右 SII 大脑区域重复治疗会增加反应的幅度和持续时间。因此，我们提出一项随机、平行组设计、双盲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有效性。患者将被随机分为假手术组或主动 rTMS 组。治疗包括连续 15 天对 SII 进行低频 rTMS。对分组情况不知情的评估者将使用以下量表对患者进行评估：疼痛视觉模拟量表、贝克抑郁量表、焦虑 VAS、临床总体印象、患者总体评估和药物减少。患者将在 3 周的基线期和 6 个月的随访期内接受评估。这项研究首次定义了这种疾病中难治性疼痛的潜在机制——体感皮层的大脑功能障碍——并提供了一种新的治疗方法。