Neuromodulation in Patients With Painful Chronic Pancreatitis

• Register: ClinicalTrials.gov
• Last refreshed on: 28 February 2022
• Main ID: NCT03357029
• Date of registration: 21/11/2017
• Prospective Registration: Yes
• Primary sponsor: Jens Brøndum Frøkjær
• Public title: Neuromodulation in Patients With Painful Chronic Pancreatitis
• Scientific 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
• Date of first enrolment: January 11, 2018
• Target sample size: 28
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03357029
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Denmark

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Painful Chronic Pancreatitis

Neuropathic Pain

Visceral Pain

Intervention(s)

Device: Sham Device

Device: GammaCore Device

Primary Outcome(s)

Detection of brain changes using magnetic resonance imaging (MRI) [Time Frame: Up to 8 weeks.]

The perceived clinical pain measured by pain diary based on Visual Analog Scale (VAS) [Time Frame: Up to 8 weeks.]

Secondary Outcome(s)

Changes in pain and physical functioning composite scores of the modified brief pain inventory-short form (mBPI-sf). [Time Frame: Up to 8 weeks.]

Blood samples [Time Frame: Up to 8 weeks.]

Patient Global Impression of Change (PGIC). [Time Frame: Up to 8 weeks.]

Quantitative sensory testing (thermal, mechanical and muscle stimulation, including conditioned pain modulation) [Time Frame: Up to 8 weeks.]

Cardiac vagal tone [Time Frame: Up to 8 weeks.]

Change in quality of life QoLQ [Time Frame: Up to 8 weeks.]

Secondary ID(s)

VNS project

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

ElectroCore INC