Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-27 @ 9:04 AM
Study NCT ID:
NCT01857492
Status:
WITHDRAWN
Last Update Posted:
2015-03-11
First Post:
2013-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
tDCS for the Management of Chronic Visceral Pain in Patients With Chronic Pancreatitis
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Study Overview
Official Title:
tDCS for the Management of Chronic Visceral Pain in Patients With Chronic Pancreatitis
Status:
WITHDRAWN
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Inactive
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
tDCS
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 Description:
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: