Clinical Trial: tDCS for the Management of Chronic Visceral Pain in Patients With Chronic Pancreatitis
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: tDCS for the Management of Chronic Visceral Pain in Patients With Chronic Pancreatitis
Brief Summary: This study is testing whether the addition of a noninvasive form of brain stimulation called transcranial direct current stimulation (tDCS) when combined with meditation helps decrease the abdominal pain in patients with chronic pancreatitis. The device involved in this study, transcranial direct current stimulation (tDCS) is investigational. This means that the study device is still being tested in research studies and is not approved by the Food and Drug Administration [FDA].
Detailed Summary: This is a double-blind, pilot study with the goal of testing the effects of tDCS coupled with meditation in the management of visceral pain in patients with chronic pancreatitis. We will enroll a total of 14 subjects with chronic pancreatitis. After enrollment, subjects will be randomized to active stimulation plus mediation (7 subjects) or sham stimulation plus meditation (7 subjects). Subjects will undergo 5 days of active tDCS stimulation plus meditation or sham tDCS plus meditation. Sessions will last approximately 30 min - 1 hour. EEG activity will be measured in the first, last and follow-up visits. After each stimulation session, we will assess for adverse effects using the tDCS adverse effects questionnaire. We will also have the subject fill out a pain/medication diary during the 5 days of treatment. All study procedures will be completed at BIDMC.
Sponsor: Beth Israel Deaconess Medical Center
Current Primary Outcome: Pain [ Time Frame: Two weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Quality of Life [ Time Frame: Two weeks ]
Original Secondary Outcome: Same as current
Information By: Beth Israel Deaconess Medical Center
Dates:
Date Received: May 16, 2013
Date Started: March 2013
Date Completion:
Last Updated: March 10, 2015
Last Verified: March 2015