NCT01857492

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 \[FDA\].

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

March 11, 2015

Status Verified

March 1, 2015

Enrollment Period

10 months

First QC Date

May 16, 2013

Last Update Submit

March 10, 2015

Conditions

Chronic PancreatitisPain

Keywords

abdominal painpancreatitischronic abdominal painvisceral painmeditationtDCSnoninvasive brain stimulationEEGKirtan Kriya

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Quality of Life

    Two weeks

Other Outcomes (1)

  • neurophysiological measures (EEG)

    Two weeks

Study Arms (2)

SHAM

SHAM COMPARATOR

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: tDCSBehavioral: Meditation

ACTIVE

ACTIVE COMPARATOR

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: tDCSBehavioral: Meditation

Interventions

tDCSDEVICE
Also known as: Soterix Medical Inc.
ACTIVESHAM
MeditationBEHAVIORAL

Both Active and SHAM groups will receive Meditation.

Also known as: Kirtan kriya Meditation
ACTIVESHAM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provide informed consent to participate in the study
  • years old
  • If taking pain medications, stable doses are required for at least 1 month prior to initiation of the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (2)

  • 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.

    PMID: 20822942BACKGROUND

  • 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. doi: 10.1002/ana.20651. No abstract available.

    PMID: 16315281BACKGROUND

Related Links

MeSH Terms

Conditions

Pancreatitis, ChronicPainAbdominal PainPancreatitisVisceral Pain

Interventions

Transcranial Direct Current StimulationMeditation

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsSigns and Symptoms, DigestiveNociceptive Pain

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological TechniquesMind-Body TherapiesComplementary TherapiesSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapy

Study Officials

  • Steven D Freedman, MD PhD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

  • Steven D. Freedman, MD, PhD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD Professor of Medicine Harvard Medical School

Study Record Dates

First Submitted

May 16, 2013

First Posted

May 20, 2013

Study Start

March 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

March 11, 2015

Record last verified: 2015-03

Locations

US(1)