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. ? ?
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