Neuromodulation in Patients With Painful Chronic Pancreatitis

NCT03357029 | Completed DMC FDA Device

• 1 other identifier: VNS project
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Conditions

Painful Chronic Pancreatitis; Visceral Pain; Neuropathic Pain

Keywords

Chronic pancreatitis; Vagal nerve stimulation; Visceral Pain

Outcome Measures

Primary Outcomes (2)

• The perceived clinical pain measured by pain diary based on Visual Analog Scale (VAS)

  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.

  Up to 8 weeks.

• Detection of brain changes using magnetic resonance imaging (MRI)

  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.

  Up to 8 weeks.

Secondary Outcomes (6)

• Change in quality of life QoLQ

  Up to 8 weeks.

• Changes in pain and physical functioning composite scores of the modified brief pain inventory-short form (mBPI-sf).

  Up to 8 weeks.

• Patient Global Impression of Change (PGIC).

  Up to 8 weeks.

• Quantitative sensory testing (thermal, mechanical and muscle stimulation, including conditioned pain modulation)

  Up to 8 weeks.

• Cardiac vagal tone

  Up to 8 weeks.

Study Arms (2)

Gammacore Device

ACTIVE COMPARATOR

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

Sham Device

SHAM COMPARATOR

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

Interventions

GammaCore Device 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.

Gammacore Device

Sham Device 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.

Sham Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jens Brøndum Frøkjær: lead
• ElectroCore INC: collaborator

Study Sites (1)

Mech-Sense, Department of Radiology

Aalborg, 9000, Denmark

Location

Related Publications (2)

• Muthulingam JA, Olesen SS, Hansen TM, Brock C, Drewes AM, Frokjaer JB. Cervical transcutaneous vagal neuromodulation in chronic pancreatitis patients with chronic pain: A randomised sham controlled clinical trial. PLoS One. 2021 Feb 26;16(2):e0247653. doi: 10.1371/journal.pone.0247653. eCollection 2021.

  PMID: 33635894 DERIVED

• Muthulingam JA, Olesen SS, Hansen TM, Brock C, Drewes AM, Frokjaer JB. Study protocol for a randomised double-blinded, sham-controlled, prospective, cross-over clinical trial of vagal neuromodulation for pain treatment in patients with chronic pancreatitis. BMJ Open. 2019 Aug 23;9(7):e029546. doi: 10.1136/bmjopen-2019-029546.

  PMID: 31603076 DERIVED

MeSH Terms

Conditions

Visceral Pain; Neuralgia; Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Nociceptive Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Professor, PhD

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: November 29, 2017
• Study Start: January 11, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: February 17, 2022

Record last verified: 2022-02

Locations

DK (1)