Clinical trial NCT01857492: tDCS for the Management of Chronic Visceral Pain in Patients With Chronic Pancreatitis
Official title: tDCS for the Management of Chronic Visceral Pain in Patients With Chronic Pancreatitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Pancreatitis
Pain
Keywords: abdominal pain
pancreatitis
chronic abdominal pain
visceral pain
meditation
tDCS
noninvasive brain stimulation
EEG
Kirtan Kriya
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Spaulding Rehabilitation Hospital
First posted: 2013-05-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain
timeFrame: Two weeks
Secondary outcomes:
measure: Quality of Life
timeFrame: Two weeks
Other outcomes:
measure: neurophysiological measures (EEG)
timeFrame: Two weeks
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Steven D Freedman, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beth Israel Deaconess Medical Center
name: Steven D. Freedman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fregni F, Potvin K, Dasilva D, Wang X, Lenkinski RE, Freedman SD, Pascual-Leone A. Clinical effects and brain metabolic correlates in non-invasive cortical neuromodulation for visceral pain. Eur J Pain. 2011 Jan;15(1):53-60. doi: 10.1016/j.ejpain.2010.08.002. Epub 2010 Sep 6.
citation: Fregni F, DaSilva D, Potvin K, Ramos-Estebanez C, Cohen D, Pascual-Leone A, Freedman SD. Treatment of chronic visceral pain with brain stimulation. Ann Neurol. 2005 Dec;58(6):971-2. doi: 10.1002/ana.20651. No abstract available.