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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-01-31

Brief Summary

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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 \[FDA\].

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Detailed Description

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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.

Conditions

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Chronic Pancreatitis Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type SHAM_COMPARATOR

tDCS

Intervention Type DEVICE

Meditation

Intervention Type BEHAVIORAL

Both Active and SHAM groups will receive Meditation.

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.

Group Type ACTIVE_COMPARATOR

tDCS

Intervention Type DEVICE

Meditation

Intervention Type BEHAVIORAL

Both Active and SHAM groups will receive Meditation.

Interventions

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tDCS

Intervention Type DEVICE

Meditation

Both Active and SHAM groups will receive Meditation.

Intervention Type BEHAVIORAL

Other Intervention Names

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Soterix Medical Inc. Kirtan kriya Meditation

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No