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Neuromodulation in Patients With Painful Chronic Pancreatitis

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ClinicalTrials.gov Identifier: NCT03357029
Recruitment Status : Recruiting
First Posted : November 29, 2017
Last Update Posted : February 19, 2019
Sponsor:
Collaborator:
ElectroCore INC
Information provided by (Responsible Party):
Jens Brøndum Frøkjær, Aalborg University Hospital

Brief Summary:
The purpose of this trial is to explore if a novel vagal neuromodulation approach provides analgesic benefit through central mechanisms in patients with chronic pancreatitis

Condition or disease Intervention/treatment Phase
Painful Chronic Pancreatitis Visceral Pain Neuropathic Pain Device: GammaCore Device Device: Sham Device Not Applicable

Detailed Description:

This study is a randomized, double blind, sham-controlled, cross-over, controlled investigation. The overall objective of the study is to conduct a study of vagal tone and the sensory system (brain activity, sensory testing, and questionnaires) assessing the effect of two weeks' transcutaneous vagal neuromodulation in chronic pancreatitis patients not responding adequately to traditional pharmacological pain treatment, in comparison to the effect of two weeks' sham treatment. The active treatment will be performed using a commercially available and validated device called GammaCore (the active treatment) while the sham treatment will be performed using a sham-device. GammaCore device is a non-invasive neurostimulator that has been approved for the treatment of anxiety, primary headache, including migraine.

The study will begin with a one-week baseline registration period, in which the patients will receive no treatment. Next, the baseline period will be followed by a 2-week treatment period where the subjects will be randomized to either active treatment or the sham treatment. Afterwards, a wash-out period of one week and a second baseline registration period of one week will occur. Finally, in the second treatment period the patients will switch in treatment assignment, meaning that patient who received active treatment in the beginning, will now receive sham treatment and vice versa. During both treatments, the patients will be asked to self-administer one stimulation dose bilaterally to the cervical vagal neck area, three times per day (morning 8 am., afternoon 2 pm, and evening 8 pm). During the whole study, subjects will be asked to complete a pain diary and several questionnaires. Moreover, at the beginning and end of each treatment period (four times), all subjects will undergo testing which will include magnetic resonance imaging (MRI), quantitative sensory testing (QST), cardiac vagal tone (CVT) and collecting blood samples.

The primary efficacy parameters to be evaluated are clinical pain relief and brain alterations using MRI.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neuromodulation in Patients With Painful Chronic Pancreatitis - A Randomized, Double-blind, Sham-controlled, Prospective, Cross-over, Controlled Study in Chronic Pain Investigating if a Novel Vagal Neuromodulation Approach Provides Analgesic Benefit Through Central Mechanisms in Patients With Chronic Pancreatitis
Actual Study Start Date : January 11, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Active Comparator: Gammacore Device
The GammaCore Device is a non-Invasive vagus nerve stimulator. One stimulation dose bilaterally to the cervical vagal neck area, three times per day (morning 8 am., afternoon 2 pm, and evening 8 pm) for two weeks
Device: GammaCore Device
GammaCore will be administered using a handheld device the size of a mobile phone, which consists of a battery powered portable stimulator with a digital control user interface that controls the stimulation amplitude and two steel contact electrodes.

Sham Comparator: Sham Device

The Sham GammaCore device looks and operates like the Active GammaCore device, but does not deliver a therapeutic stimulation treatment.

One stimulation dose bilaterally to the cervical vagal neck area, three times per day (morning 8 am., afternoon 2 pm, and evening 8 pm) for two weeks.

Device: Sham Device
Sham device will be administered using a handheld device the size of a mobile phone, which consists of a battery powered portable stimulator with a digital control user interface that controls the stimulation amplitude and two steel contact electrodes. The sham device is identical in appearance, weight, visual and audible feedback, and user application and control but did not deliver electrical stimulations.




Primary Outcome Measures :
  1. The perceived clinical pain measured by pain diary based on Visual Analog Scale (VAS) [ Time Frame: Up to 8 weeks. ]
    The primary clinical efficacy parameter to be evaluated is pain relief. In the clinical part of the study the efficacy is assessed as changes in the daily experience of pain, which will be measured using a patient pain diary based on the visual analog scale (VAS). Maximum intensity and average daily VAS will be recorded on daily basis.

  2. Detection of brain changes using magnetic resonance imaging (MRI) [ Time Frame: Up to 8 weeks. ]
    The primary experimental endpoint is detection of structural, functional, metabolic brain alterations using MRI techniques in order to study the brain mechanisms involved in chronic pain and central sensitization.


Secondary Outcome Measures :
  1. Change in quality of life QoLQ [ Time Frame: Up to 8 weeks. ]
  2. Changes in pain and physical functioning composite scores of the modified brief pain inventory-short form (mBPI-sf). [ Time Frame: Up to 8 weeks. ]
  3. Patient Global Impression of Change (PGIC). [ Time Frame: Up to 8 weeks. ]
  4. Quantitative sensory testing (thermal, mechanical and muscle stimulation, including conditioned pain modulation) [ Time Frame: Up to 8 weeks. ]
  5. Cardiac vagal tone [ Time Frame: Up to 8 weeks. ]
  6. Blood samples [ Time Frame: Up to 8 weeks. ]
    Changes in cytokines will be assessed .



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients from the ages of 18 with a diagnosis of CP diagnosed using the Mayo Clinic diagnostic criteria.
  • The participants must be able to read and understand Danish.
  • The patients must suffer from chronic abdominal pain characteristic for CP, meet the criteria for chronic pain (pain ≥ 3 days per week in at least 3 months) and must consider their pain as insufficiently treated with their usual analgesic treatment.
  • Personally, signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial as well as signing the following document: "Informeret samtykke om opbevaring af biologisk material i biobank til fremtidig forskning".
  • Personally, signed and dated the Power of attorney document (Fuldmagtserklæring) indicating that the patient has accepted that the Danish Medical Agency Sundhedsstyrelsen/Lægemiddelstyrelen) have access to the medical records.
  • Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other trial procedures.

Exclusion Criteria:

  • Patients with any clinically significant abnormalities that in the opinion of the investigator may increase the risk associated with trial participation or may interfere with the interpretation of the trial results.
  • Alcohol dependence (Alcohol use in accordance with the recommendations by the Danish Health and Medicines Authority are allowed).
  • Illegal drug dependencies.
  • Participating in another study where investigational drug is used.
  • Patients must not suffer from painful conditions other than CP that make them unable to distinguish the pain associated with CP from chronic pain of other origin.
  • Cardiovascular diseases
  • Low blood pressure < 100/60
  • Not able to understand or follow the instructions.
  • Any condition with elevated intracranial pressure.
  • Female patients who are pregnant or lactating, or intend to become pregnant and male patients who intend to father a child during the course of the study. A pregnancy test will be conducted at baseline and after 8 weeks to ensure that female patients are not pregnant during the study medication period. The investigator will have to urge that fertile female patients use a safe contraception method during the study and for at least 15 hours after termination of the study medication period. The following methods are considered as safe contraception methods:

    • The combined oral contraceptive pill
    • Intra uterine device
    • Gestagen injection
    • Subdermal implantation
    • Hormone vaginal ring
    • Transdermal plaster
  • Contraindications for MRI: Such as metallic Foreign Body in the Eye, "Triggerfish" Contact Lens, Gastric Reflux Device, Insulin Pumps, Permanent pacemaker, Temporary external transvenous pacing leads, Other implantable metallic components which is considered unsafe by the medical doctor.
  • Previous surgery on vagus nerve.
  • Known neuropathy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03357029


Contacts
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Contact: Jens Brøndum Frøkjær, MD, Professor, PhD +4597665105 jebf@rn.dk
Contact: Janusiya Muthulingam, MSc, PhD-Student jmuthulingam@rn.dk

Locations
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Denmark
Mech-Sense, Department of Radiology Recruiting
Aalborg, Denmark, 9000
Contact: Jens Brøndum Frøkjær, MD, Professor, PhD       jebf@rn.dk   
Contact: Janusiya Muthulingam, MSc, PhD-Student         
Principal Investigator: Jens Brøndum Frøkjær, MD, Professor, PhD         
Sub-Investigator: Asbjørn Mohr Drewes, MD, Professor, PhD         
Sub-Investigator: Søren Schou Olesen, MD, PhD         
Sponsors and Collaborators
Jens Brøndum Frøkjær
ElectroCore INC

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Responsible Party: Jens Brøndum Frøkjær, MD, Professor, PhD, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT03357029     History of Changes
Other Study ID Numbers: VNS project
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Jens Brøndum Frøkjær, Aalborg University Hospital:
Chronic pancreatitis
Vagal nerve stimulation
Visceral Pain
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Chronic
Neuralgia
Pain
Visceral Pain
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Pancreatic Diseases
Digestive System Diseases
Nociceptive Pain