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

March 10, 2015 updated by: Steven Freedman, Beth Israel Deaconess Medical Center
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].

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Soterix Medical Inc.
Behavioral: Meditation
Both Active and SHAM groups will receive Meditation.
Other Names:
  • 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 Names:
  • Soterix Medical Inc.
Behavioral: Meditation
Both Active and SHAM groups will receive Meditation.
Other Names:
  • Kirtan kriya Meditation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: Two weeks
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
Two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: Two weeks
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
Two weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
neurophysiological measures (EEG)
Time Frame: Two weeks
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.
Two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

May 16, 2013

First Submitted That Met QC Criteria

May 16, 2013

First Posted (Estimate)

May 20, 2013

Study Record Updates

Last Update Posted (Estimate)

March 11, 2015

Last Update Submitted That Met QC Criteria

March 10, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-P-000033

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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