Trial record 5 of 98 for:    Open Studies | "Pancreatitis"

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

This study is currently recruiting participants.
Verified May 2013 by Beth Israel Deaconess Medical Center
Sponsor:
Collaborator:
Spaulding Rehabilitation Hospital
Information provided by (Responsible Party):
Steven Freedman, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01857492
First received: May 16, 2013
Last updated: NA
Last verified: May 2013
History: No changes posted
  Purpose

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].


Condition Intervention
Chronic Pancreatitis
Pain
Device: tDCS
Behavioral: Meditation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: tDCS for the Management of Chronic Visceral Pain in Patients With Chronic Pancreatitis

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Pain [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
    Assess the effects of 5 days of active vs sham tDCS stimulation plus meditation on chronic visceral pain in patients with chronic pancreatitis. We will determine the magnitude of pain reduction using the Visual Analog Scale (VAS) score and Brief Pain Inventory (BPI). We hypothesize that active tDCS plus meditation will have a greater decrease in VAS scores and BPI scores when compared to sham tDCS plus meditation in subjects with chronic pancreatitis


Secondary Outcome Measures:
  • Quality of Life [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
    Assess the effects of 5 days of active vs sham tDCS stimulation plus meditation on life satisfaction in subjects with chronic pancreatitis. We will use the Quality of Life Scale (QoLS) to assess changes in life satisfaction after active tDCS plus meditation intervention. We hypothesize that active tDCS plus meditation will have a greater increase in the QoLS after the intervention when compared to sham tDCS plus mediation in subjects with chronic pancreatitis


Other Outcome Measures:
  • neurophysiological measures (EEG) [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
    Determine whether treatment with active tDCS coupled with meditation changes cortical activity as assessed with electroencephalography (EEG). We hypothesize that active tDCS plus meditation will have a greater increase in alpha activity and a greater inhibition in beta activity and this will be associated with a greater reduction in pain when compared to sham tDCS plus meditation in patients with chronic pancreatitis.


Estimated Enrollment: 14
Study Start Date: March 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: SHAM
We will apply sham tDCS on the primary motor cortex. We will use the same montage and parameters of active tDCS. However the current will be applied for 30 seconds in the beginning of the procedure and after that the current is turned off. This parameter for sham stimulation was chosen based on previous studies that have shown that perceived sensations on the scalp such as tingling usually fade out in the first 30 seconds of tDCS. It should be noted that less than 3 minutes of tDCS induces no effects on cortical excitability [29] and also using 30 seconds of sham is a reliable method of blinding as shown by a randomized controlled study [30]. Subjects will also meditate while receiving stimulation
Device: tDCS
Other Name: Soterix Medical Inc.
Behavioral: Meditation
Both Active and SHAM groups will receive Meditation.
Other Name: Kirtan kriya Meditation
Active Comparator: ACTIVE
A 1x1 Low-intensity DC Stimulator such as the Soterix Medical Inc. (Model 1224-B New York, NY, USA) or an equivalent device will be used to deliver direct current through 35cm² saline-soaked electrodes. The anodal electrode will be placed over the left primary motor cortex (M1) while the cathodal electrode will be placed over the contralateral supra-orbital area. Primary motor cortex will be localized using the 10/20 EEG system (C3 or C4) and this is a reliable method for the technique of tDCS [5]. During active tDCS, a 2mA constant current will be delivered for 20 minutes while the subject meditates. The primary motor cortex is a reliable "entry port" to modulate dysfunctional activity in pain-related neural networks.
Device: tDCS
Other Name: Soterix Medical Inc.
Behavioral: Meditation
Both Active and SHAM groups will receive Meditation.
Other Name: Kirtan kriya Meditation

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01857492

Contacts
Contact: Deborah A DaSilva, RN 617 667 2399 ddasilva@bidmc.harvard.edu
Contact: Gyanprakash Ketwaroo, MD 617 667 1236 gketwaroo@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Steven D Freedman, MD PhD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Spaulding Rehabilitation Hospital
Investigators
Principal Investigator: Steven D Freedman, MD PhD Beth Israel Deaconess Medical Center
Principal Investigator: Steven D. Freedman, MD, PhD Beth Israel Deaconess Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: Steven Freedman, MD PhD Professor of Medicine Harvard Medical School, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01857492     History of Changes
Other Study ID Numbers: 2013-P-000033
Study First Received: May 16, 2013
Last Updated: May 16, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Beth Israel Deaconess Medical Center:
abdominal pain
pancreatitis
chronic abdominal pain
visceral pain
meditation
tDCS
noninvasive brain stimulation
EEG
Kirtan Kriya

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 21, 2014