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

Pain Clinical Trial

— tDCS  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01857492
• Other study ID #: 2013-P-000033
• Status: Withdrawn
• Phase: N/A
• First received: May 16, 2013
• Last updated: March 10, 2015
• Start date: March 2013
• Est. completion date: January 2014

Study information

• Verified date: March 2015
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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].

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Pain
• Pancreatitis
• Pancreatitis, Chronic
• Visceral Pain

Intervention

Device:
• tDCS

Behavioral:
• Meditation
Both Active and SHAM groups will receive Meditation.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	neurophysiological measures (EEG)	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	No
Primary	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	Two weeks	No
Secondary	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	Two weeks	No

External Links

•   Pancreas Center at Beth Israel Deaconess Medical Center