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

Primary Purpose

Chronic Pancreatitis, Pain

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tDCS
Meditation
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pancreatitis focused on measuring abdominal pain, pancreatitis, chronic abdominal pain, visceral pain, meditation, tDCS, noninvasive brain stimulation, EEG, Kirtan Kriya

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

SHAM

ACTIVE

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Pain
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
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

Full Information

First Posted
May 16, 2013
Last Updated
March 10, 2015
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Spaulding Rehabilitation Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01857492
Brief Title
tDCS for the Management of Chronic Visceral Pain in Patients With Chronic Pancreatitis
Acronym
tDCS
Official Title
tDCS for the Management of Chronic Visceral Pain in Patients With Chronic Pancreatitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Inactive
Study Start Date
March 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Spaulding Rehabilitation Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pancreatitis, Pain
Keywords
abdominal pain, pancreatitis, chronic abdominal pain, visceral pain, meditation, tDCS, noninvasive brain stimulation, EEG, Kirtan Kriya

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SHAM
Arm Type
Sham Comparator
Arm Description
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
Arm Title
ACTIVE
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
tDCS
Other Intervention Name(s)
Soterix Medical Inc.
Intervention Type
Behavioral
Intervention Name(s)
Meditation
Other Intervention Name(s)
Kirtan kriya Meditation
Intervention Description
Both Active and SHAM groups will receive Meditation.
Primary Outcome Measure Information:
Title
Pain
Description
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
Time Frame
Two weeks
Secondary Outcome Measure Information:
Title
Quality of Life
Description
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
Time Frame
Two weeks
Other Pre-specified Outcome Measures:
Title
neurophysiological measures (EEG)
Description
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.
Time Frame
Two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provide informed consent to participate in the study 18 years old If taking pain medications, stable doses are required for at least 1 month prior to initiation of the study Exclusion Criteria: History of alcohol or substance abuse within the last 6 months as self-reported Suffering from severe depression (with a score of >30 in the Beck Depression Inventory) Diagnosis of any neurological diseases (such as epilepsy) Episodes of seizures within the last 6 months Unexplained loss of consciousness Use of carbamazepine or neuropsychotropic drugs Have had no neurosurgery as self reported Contraindications to tDCS Metal in the head Implanted brain medical devices Pregnant at time of enrollment Previous experience with meditation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven D Freedman, MD PhD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven D. Freedman, MD, PhD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20822942
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.
Results Reference
background
PubMed Identifier
16315281
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.
Results Reference
background

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

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