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

Beth Israel Lahey Health

Status: Withdrawn

Conditions: Chronic Pancreatitis; Pain

Treatments: Behavioral: Meditation; Device: tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT01857492

2013-P-000033

Details and patient eligibility

About

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].

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

SHAM

Sham Comparator group

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

Treatment:

Device: tDCS

Behavioral: Meditation

ACTIVE

Active Comparator group

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.

Treatment:

Device: tDCS

Behavioral: Meditation