tDCS for the Management of Chronic Visceral Pain in Patients With Chronic Pancreatitis

tDCS for the Management of Chronic Visceral Pain in Patients With Chronic Pancreatitis

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].

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.

Inclusion Criteria:

1. Provide informed consent to participate in the study
2. 18 years old
3. If taking pain medications, stable doses are required for at least 1 month prior to initiation of the study

Exclusion Criteria:

1. History of alcohol or substance abuse within the last 6 months as self-reported

2. Suffering from severe depression (with a score of >30 in the Beck Depression Inventory)

3. Diagnosis of any neurological diseases (such as epilepsy)

4. Episodes of seizures within the last 6 months

5. Unexplained loss of consciousness

6. Use of carbamazepine or neuropsychotropic drugs

7. Have had no neurosurgery as self reported

8. Contraindications to tDCS

   1. Metal in the head
   2. Implanted brain medical devices

9. Pregnant at time of enrollment

10. Previous experience with meditation