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. ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Small Research Grants (R03)
Project #
5R03DK071851-02
Application #
7108601
Study Section
Special Emphasis Panel (ZDK1-GRB-8 (M2))
Program Officer
Robuck, Patricia R
Project Start
2005-08-15
Project End
2008-07-31
Budget Start
2006-08-01
Budget End
2008-07-31
Support Year
2
Fiscal Year
2006
Total Cost
$166,005
Indirect Cost
Name
Beth Israel Deaconess Medical Center
Department
Type
DUNS #
071723621
City
Boston
State
MA
Country
United States
Zip Code
02215
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Rigonatti, Sergio P; Boggio, Paulo S; Myczkowski, Martin L et al. (2008) Transcranial direct stimulation and fluoxetine for the treatment of depression. Eur Psychiatry 23:74-6
Edwards, Dylan; Fregni, Felipe (2008) Modulating the healthy and affected motor cortex with repetitive transcranial magnetic stimulation in stroke: development of new strategies for neurorehabilitation. NeuroRehabilitation 23:3-14
Boggio, Paulo S; Rigonatti, Sergio P; Ribeiro, Rafael B et al. (2008) A randomized, double-blind clinical trial on the efficacy of cortical direct current stimulation for the treatment of major depression. Int J Neuropsychopharmacol 11:249-54
Fregni, Felipe; Pascual-Leone, Alvaro; Freedman, Steven D (2007) Pain in chronic pancreatitis: a salutogenic mechanism or a maladaptive brain response? Pancreatology 7:411-22
Fecteau, Shirley; Knoch, Daria; Fregni, Felipe et al. (2007) Diminishing risk-taking behavior by modulating activity in the prefrontal cortex: a direct current stimulation study. J Neurosci 27:12500-5
Fregni, Felipe; Pascual-Leone, Alvaro (2007) Technology insight: noninvasive brain stimulation in neurology-perspectives on the therapeutic potential of rTMS and tDCS. Nat Clin Pract Neurol 3:383-93
Roizenblatt, Suely; Fregni, Felipe; Gimenez, Rafaela et al. (2007) Site-specific effects of transcranial direct current stimulation on sleep and pain in fibromyalgia: a randomized, sham-controlled study. Pain Pract 7:297-306
Fecteau, Shirley; Pascual-Leone, Alvaro; Zald, David H et al. (2007) Activation of prefrontal cortex by transcranial direct current stimulation reduces appetite for risk during ambiguous decision making. J Neurosci 27:6212-8

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