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
|Condition or disease||Intervention/treatment||Phase|
|Painful Chronic Pancreatitis Visceral Pain Neuropathic Pain||Device: GammaCore Device Device: Sham Device||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||21 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
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.
- 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.
- 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.
- Change in quality of life QoLQ [ Time Frame: Up to 8 weeks. ]
- Changes in pain and physical functioning composite scores of the modified brief pain inventory-short form (mBPI-sf). [ 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. ]
- Blood samples [ Time Frame: Up to 8 weeks. ]Changes in cytokines will be assessed .
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
|Contact: Jens Brøndum Frøkjær, MD, Professor, PhDemail@example.com|
|Contact: Janusiya Muthulingam, MSc, PhD-Studentfirstname.lastname@example.org|
|Mech-Sense, Department of Radiology||Recruiting|
|Aalborg, Denmark, 9000|
|Contact: Jens Brøndum Frøkjær, MD, Professor, PhD email@example.com|
|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|