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Sponsored by: |
Beth Israel Deaconess Medical Center |
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Information provided by: | Beth Israel Deaconess Medical Center |
ClinicalTrials.gov Identifier: | NCT00130052 |
The researchers aim to study the effects of repetitive transcranial magnetic stimulation (rTMS) on chronic pain in patients with chronic pancreatitis and functional gastrointestinal disorders.
Condition | Intervention | Phase |
---|---|---|
Pain Pancreatitis Functional Gastrointestinal Disorders |
Procedure: Transcranial Magnetic Stimulation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | The Effect of 10-Day Treatment of Repetitive Transcranial Magnetic Stimulation on Abdominal Pain in Patients With Chronic Pancreatitis or Functional Gastrointestinal Disorders |
Estimated Enrollment: | 32 |
Study Start Date: | November 2004 |
The purpose of this protocol is to investigate a possible novel treatment for intractable visceral pain in patients with chronic pancreatitis and functional gastrointestinal disorders. Pain is a major contributor to the poor quality of life in this patient population. The refractory nature of this condition to medical and surgical procedures prompted us to hypothesize that one mechanism leading to pain in these patients is the dysfunction of brain cortical regulation of visceral sensation. This notion is particularly supported by findings that patients with chronic pancreatitis can continue to experience disabling pain even after total pancreatectomy, suggesting that symptoms are sustained by a pancreas-independent, neural-based mechanism.
Visceral sensation is particularly processed in the secondary somatosensory area - SII. Therefore, chronic pancreatitis pain may be sustained by a dysfunction of SII rather than by pancreatic inflammation alone. The researchers hypothesize further, that the dysfunction of SII is one of hyper-excitability. According to this hypothesis, suppression of SII activity may help control the pain in patients with chronic pancreatitis. Temporary inhibition of SII activity can be obtained by a novel tool, namely transcranial magnetic stimulation (TMS), which can suppress brain excitability noninvasively beyond the duration of the TMS if appropriate stimulation parameters are employed. In the initial sham controlled, double blind pilot trial of 5 subjects with idiopathic chronic pancreatitis, TMS applied to SII resulted in significant pain improvement in 3 of the subjects. The researchers will rigorously test the hypothesis that chronic pancreatitis pain is sustained by a dysfunction of SII characterized by hyperexcitability through two specific aims:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients will be eligible if:
The diagnosis of chronic pancreatitis will be based on the existence of chronic abdominal pain and at least one of the four following criteria:
Other causes of chronic pancreatitis will be excluded as follows:
Exclusion Criteria:
Participants will be excluded if there are known complications of chronic pancreatitis requiring interventions including pseudocysts or pancreatic duct obstruction or if there is the presence of cancer. In addition, in order to minimize the risk of TMS, the following exclusion criteria will be followed:
Contact: Felipe Fregni, MD | 617-667-5272 | ffregni@bidmc.harvard.edu |
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Principal Investigator: Steven D Freedman, MD, PhD | |
Sub-Investigator: Alvaro Pascual-Leone, MD, PhD | |
Sub-Investigator: Felipe Fregni, MD | |
Sub-Investigator: Kimberly M Potvin, BA | |
Sub-Investigator: Deborah Dasilva, BS |
Principal Investigator: | Steven D Freedman, MD, PhD | Beth Israel Deaconess Medical Center/ Harvard Medical School |
Study ID Numbers: | 2004P-000352 |
Study First Received: | August 11, 2005 |
Last Updated: | May 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00130052 History of Changes |
Health Authority: | United States: Institutional Review Board |
analgesia electric stimulation therapy electric stimulation pain safety |
Digestive System Diseases Abdominal Pain Gastrointestinal Diseases Pancreatic Diseases |
Pain Pancreatitis Pancreatitis, Chronic |
Digestive System Diseases Pathologic Processes Disease Gastrointestinal Diseases |
Pancreatic Diseases Pancreatitis Pancreatitis, Chronic |