tDCS for the Management of Chronic Visceral Pain in Patients With Chronic Pancreatitis
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/8/2015 |
| Start Date: | March 2013 |
| End Date: | March 2014 |
| Contact: | Deborah A DaSilva, RN |
| Email: | ddasilva@bidmc.harvard.edu |
| Phone: | 617 667 2399 |
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].
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.
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
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