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Chronic PancreatitistDCSNCT01857492

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

A study testing tDCS and Meditation in people with Chronic Pancreatitis and Pain, run by Beth Israel Deaconess Medical Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Pancreatitis, Pain
What is being tested?
tDCS and Meditation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
Mar 2013to Jan 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

Other trials in United States

About this study

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].

Read the 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.

Being tested
tDCS, Meditation
Keywords
abdominal pain, pancreatitis, chronic abdominal pain, visceral pain, meditation, tDCS, noninvasive brain stimulation, EEG, Kirtan Kriya
Medical subject headings
Pancreatitis, Chronic, Pain, Abdominal Pain, Pancreatitis, Visceral Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tDCSDevice

    Also called Soterix Medical Inc.

  • MeditationBehavioural

    Also called Kirtan kriya Meditation

    Both Active and SHAM groups will receive Meditation.

Study groups in NCT01857492
Study groupRoleWhat they receive
SHAMSham comparatorWe 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
Receives: Device: tDCS; Behavioral: Meditation
ACTIVEActive comparatorA 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.
Receives: Device: tDCS; Behavioral: Meditation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Two weeks

Secondary outcomes (1)

  1. 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

    Measured: Two weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionJan 2014
  4. Study completionJan 2014

Why it stopped: Inactive

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01857492
Sponsor's protocol ID
2013-P-000033
Acronym
tDCS
Status last verified
Mar 2015
First submitted
16 May 2013
Last updated
11 Mar 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20822942

  • 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.

    PubMed 16315281

Questions about this trial

What is this clinical trial studying?

A study testing tDCS and Meditation in people with Chronic Pancreatitis and Pain, run by Beth Israel Deaconess Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain (time frame: Two weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01857492, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2015; AzTrials last refreshed its copy on 8 Nov 2026.

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