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

Sponsor

Beth Israel Deaconess Medical Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01857492

Collaborator

Spaulding Rehabilitation Hospital (Other)

Enrollment

Location

Arms

10.1

Duration (Months)

Patients Per Site Per Month

Study Details

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].

Condition or Disease	Intervention/Treatment	Phase
Chronic Pancreatitis Pain	Device: tDCS Behavioral: Meditation	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

Jan 1, 2014

Actual Study Completion Date :

Jan 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Pain [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

Secondary Outcome Measures

Quality of Life [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

Other Outcome Measures

neurophysiological measures (EEG) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215

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